Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF Sy...

FDA Device Recall #Z-1221-2023 — Class II — February 7, 2023

Recall Summary

Recall Number Z-1221-2023
Classification Class II — Moderate risk
Date Initiated February 7, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm St. Jude Medical
Location Atlanta, GA
Product Type Devices
Quantity 1,905 units

Product Description

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

Reason for Recall

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.

Lot / Code Information

UDI/DI 05415067029331, Serial Numbers: M140100179, M140100180, M140100181, M140100182, M140100183, M140100184, M140100185, M140100186, M140200187, M140200188, M140200190, M140200191, M140200193, M140200196, M140200204, M140200205, M140200213, M140200215, M140200216, M140200218, M140200220, M140200221, M140200223, M140200224, M140200226, M140200228, M140200230, M140200233, M140200234, M140200235, M140200237, M140200238, M140200240, M140200243, M140200245, M140400469, M140400470, M140400471, M140400472, M140400474, M140600522, M140600530, M140600532, M140600536, M140600537, M140600538, M140600541, M140600542, M140600543, M140600545, M140600546, M140700687, M140700688, M140700689, M140700690, M140700691, M140700692, M140700693, M140700694, M140700698, M140700699, M140700700, M140700701, M140700703, M140700705, M140700710, M140700712, M140700713, M140700714, M140700715, M140700717, M140700718, M140700721, M140700722, M140700725, M140700726, M140700799, M140700800, M140700801, M140700804, M140700806, M140700817, M140700818, M140800820, M140800821, M140800822, M140800825, M140800827, M140800828, M140800829, M140800833, M140800835, M140800837, M140800838, M140800839, M140800841, M140800842, M140800846, M140800848, M140800849, M140800850, M140800853, M140800855, M140800856, M140800859, M140800861, M140800862, M140800864, M140800867, M140800868, M140800869, M140800872, M140800874, M140800876, M140800877, M140800879, M140800880, M140800881, M140800883, M140800886, M140800887, M140800890, M140800891, M140800895, M140800896, M140800918, M140800919, M140800922, M140800925, M140800926, M140901157, M140901158, M140901159, M140901160, M140901161, M140901162, M140901163, M140901164, M140901166, M140901169, M140901172, M140901174, M140901175, M140901177, M140901184, M140901185, M140901186, M141001337, M141001339, M141001341, M141001344, M141001345, M141001353, M141001354, M141001355, M141001356, M141001358, M141001359, M141001360, M141001361, M141001362, M141001363, M141001366, M141201849, M141201857, M141201859, M141201861, M141201862, M141201863, M141201865, M141201866, M141201867, M141201869, M141201870, M141201871, M141201873, M141201874, M141201876, M141201879, M141201880, M141201882, M141201883, M141201885, M141201886, M141201887, M141201889, M141201890, M141201891, M141201893, M141201894, M141201895, M141201897, M141201898, M141201899, M141201900, M141201901, M141201902, M141201903, M141201904, M141201906, M150102237, M150102238, M150102239, M150102241, M150102243, M150102245, M150102246, M150102248, M150102253, M150102254, M150102255, M150102257, M150102259, M150102260, M150102261, M150102263, M150102265, M150102266, M150202497, M150202498, M150202499, M150202502, M150202503, M150202504, M150202505, M150202507, M150202509, M150202512, M150202514, M150202516, M150202526, M150302647, M150302649, M150302650, M150302652, M150302655, M150402907, M150402911, M150402912, M150402914, M150402916, M150402918, M150402919, M150402920, M150402921, M150402922, M150402924, M150402925, M150402926, M150402927, M150402929, M150402931, M150402932, M150402934, M150402935, M150402937, M150402938, M150402941, M150402942, M150402943, M150402944, M150402945, M150402946, M150403187, M150403188, M150403189, M150403190, M150403191, M150403192, M150403193, M150403194, M150503377, M150503378, M150503379, M150503380, M150503381, M150503384, M150503385, M150503390, M150503391, M150503393, M150503397, M150503398, M150503400, M150503401, M150503404, M150503407, M150503409, M150503410, M150503411, M150503413, M150503414, M150503415, M150503416, M150503419, M150503420, M150503423, M150503424, M150704378, M150704379, M150704380, M150704381, M150704383, M150704384, M150704385, M150704386, M150704387, M150704389, M150704391, M150704393, M150704397, M150704398, M150704399, M150704401, M150704403, M150704405, M150704407, M150704412, M150704413, M150704414, M150704416, M150704417, M150704418, M150704419, M150704420, M150704421, M150704422, M150704423, M150704424, M150704426, M150804897, M150804899, M150804901, M150804903, M150804904, M150804906, M150804907, M150804908, M150804909, M150804910, M150804911, M150804912, M150804914, M150804915, M150804916, M150804917, M150804918, M150804919, M150804920, M150804921, M150804922, M150804923, M150804924, M150804926, M150804927, M150804929, M150804932, M150804933, M150804934, M150804935, M150804936, M150804937, M150804938, M150804939, M150804943, M150804944, M150804945, M150804947, M150804948, M150804949, M150804950, M150804951, M150804952, M150804953, M150804954, M150804955, M150905408, M150905410, M150905411, M150905412, M150905413, M150905414, M150905415, M150905416, M150905417, M150905418, M150905419, M150905420, M150905424, M150905426, M150905427, M150905428, M150905429, M150905430, M150905431, M150905432, M150905433, M150905435, M150905717, M150905718, M150905719, M150905721, M150905722, M150905724, M150905728, M150905729, M150905730, M150905731, M150905732, M150905734, M150905739, M150905740, M150905741, M150905742, M150905745, M151005983, M151005988, M151005989, M151005994, M151005995, M151106357, M151106359, M151106362, M151106363, M151106364, M151106366, M151106367, M151106368, M151106369, M151106371, M151106372, M151106375, M151106376, M151106381, M151106382, M151106385, M151106387, M151106389, M151106390, M151106391, M151106392, M151106393, M151106394, M151106396, M151106397, M151106398, M151106399, M151106400, M151106401, M151106403, M151106404, M151106405, M151206527, M151206528, M151206530, M151206531, M151206533, M151206537, M151206539, M151206540, M151206541, M151206542, M151206544, M151206545, M151206546, M151206548, M151206549, M151206550, M151206551, M151206554, M151206556, M151206558, M151206559, M151206560, M151206561, M151206563, M151206566, M160307210, M160307211, M160307214, M160307219, M160307221, M160307223, M160307224, M160307226, M160307227, M160307234, M160707625, M160807677, M160807678, M160807679, M160807680, M160807682, M160807683, M160807684, M160807685, M160807687, M160807690, M160807692, M161107927, M161107928, M161107929, M161107930, M161107931, M161107932, M161107933, M161107934, M161107935, M161107936, M161107937, M161107938, M161107939, M161107940, M161107941, M161107942, M161107943, M161107944, M161107945, M161207947, M161207948, M161207953, M161207955, M161207956, M161207957, M161207958, M161207959, M161207960, M161207961, M161207962, M161207963, M161207964, M161207965, M161207968, M161207969, M161207970, M161207972, M161207973, M161207974, M161207975, M161207976, M161207978, M161207980, M161207981, M161207983, M161207984, M161207985, M161208049, M161208065, M161208066, M161208067, M161208068, M161208069, M161208070, M161208071, M161208072, M161208073, M161208074, M161208075, M161208076, M161208077, M161208078, M161208079, M161208080, M161208081, M161208082, M161208084, M170108086, M170108087, M170108088, M170108089, M170108090, M170108091, M170108092, M170108093, M170108095, M170108096, M170108097, M170108098, M170108100, M170108101, M170108102, M170108103, M170108104, M170108106, M170108107, M170108108, M170108109, M170108110, M170108111, M170108112, M170108113, M170108114, M170108115, M170108119, M170108120, M170108122, M170108123, M170108124, M170108125, M170108126, M170108127, M170108130, M170108131, M170108132, M170108133, M170108134, M170108135, M170108136, M170108137, M170108138, M170108140, M170108141, M170108142, M170108144, M170108145, M170108146, M170108147, M170108148, M170108149, M170108150, M170108153, M170108154, M170108155, M170108156, M170108157, M170208158, M170208159, M170208160, M170208161, M170208162, M170208163, M170208164, M170208165, M170208166, M170208167, M170208168, M170208169, M170208170, M170208171, M170208172, M170208173, M170208174, M170208175, M170208176, M170208177, M170208178, M170208179, M170208181, M170208182, M170208183, M170208184, M170208185, M170208187, M170308188, M170308190, M170308191, M170308192, M170308193, M170308194, M170308195, M170308196, M170308197, M170308200, M170308201, M170308202, M170308203, M170308204, M170308205, M170308206, M170308207, M170308208, M170308209, M170308210, M170308211, M170308212, M170308213, M170308214, M170308215, M170408216, M170408217, M170408218, M170408219, M170408220, M170408222, M170408223, M170408224, M170408225, M170408226, M170408227, M170408228, M170408229, M170408230, M170408231, M170408232, M170408233, M170408234, M170408235, M170408240, M170408241, M170408242, M170408243, M170408244, M170408246, M170408249, M170408250, M170408252, M170408253, M170408254, M170408255, M170408256, M170408257, M170408259, M170508260, M170508261, M170508275, M170608293, M170608294, M170608295, M170608296, M170608297, M170708308, M170708309, M170708310, M170708311, M170708313, M170708314, M170708315, M170708316, M170708317, M170708321, M170708323, M170708339, M170808325, M170808326, M170808328, M170808329, M170808336, M170808337, M170808338, M170808340, M170808341, M170808342, M170808344, M170808345, M170808346, M170808347, M170808352, M170808353, M170808357, M170908358, M170908360, M170908361, M170908362, M170908364, M170908366, M170908367, M170908368, M170908369, M170908370, M170908371, M170908372, M170908373, M170908374, M170908377, M170908378, M170908380, M170908383, M170908384, M170908387, M170908389, M170908390, M170908392, M170908393, M170908394, M170908395, M170908396, M171108397, M171108398, M171108399, M171108400, M171108402, M171108403, M171108406, M171108407, M171108408, M171108409, M171108410, M171108412, M171108413, M171108414, M171108415, M171108416, M171108417, M171108419, M171108422, M171108423, M171108424, M171108425, M171108426, M171108427, M171108428, M171108429, M171108430, M171108431, M171108432, M171108433, M171108436, M171108437, M171108438, M171108439, M171108440, M171108441, M171108442, M171108443, M180108444, M180108445, M180108451, M180108453, M180108455, M180108456, M180108457, M180108459, M180108460, M180108462, M180108464, M180108465, M180108467, M180108468, M180108469, M180108470, M180108471, M180108472, M180108474, M180208475, M180208476, M180208479, M180208480, M180208481, M180208482, M180208483, M180208484, M180208485, M180208488, M180208489, M180208491, M180208492, M180208493, M180208494, M180208495, M180208497, M180208498, M180208499, M180208501, M180208502, M180208503, M180208504, M180208505, M180208506, M180208507, M180208509, M180208510, M180208511, M180208512, M180208514, M180208517, M180308526, M180308527, M180308529, M180308535, M180308537, M180308539, M180408540, M180408543, M180408544, M180408545, M180408546, M180408549, M180408551, M180408552, M180408553, M180408554, M180408555, M180408556, M180408557, M180408562, M180408574, M180408575, M180408576, M180408577, M180408578, M180408579, M180408580, M180408583, M180408584, M180408585, M180408586, M180408587, M180408588, M180408589, M180408590, M180408591, M180508593, M180508596, M180508598, M180508600, M180508601, M180508602, M180508603, M180508604, M180508605, M180508606, M180508607, M180508608, M180508611, M180508617, M180508619, M180508620, M180508627, M180508629, M180508630, M180508631, M180608632, M180608634, M180608635, M180608637, M180608638, M180608639, M180608642, M180608643, M180608644, M180608645, M180608646, M180608647, M180608648, M180608649, M180608651, M180608652, M180608653, M180608655, M180608656, M180608657, M180608658, M180608659, M180608660, M180608661, M180608662, M180608663, M180608667, M180608668, M180608669, M180608670, M180608671, M180608672, M180608673, M180608674, M180608677, M180608678, M180608679, M180608680, M180608681, M180608683, M180608684, M180608689, M180608690, M180608691, M180608692, M180608693, M180608694, M180608697, M180608698, M180608699, M180608700, M180608701, M180608702, M180608707, M180608708, M180608710, M180608711, M180608712, M180608713, M180608714, M180608717, M180608718, M180608719, M180608720, M180608721, M180608722, M180608723, M180608724, M180608725, M180608726, M180608727, M180608728, M180608730, M180608731, M180608732, M180608734, M180608735, M180608736, M180608737, M180608738, M180608739, M180608740, M180608743, M180608745, M180608746, M180608747, M180608748, M180608749, M180608750, M180608751, M180608752, M180608753, M180608754, M180608755, M180608756, M180608757, M180608758, M180608759, M180608760, M180608762, M180608763, M180608764, M180608765, M180608766, M180608768, M180608769, M180608770, M180608772, M180608773, M180608774, M180608775, M180608776, M180608777, M180608778, M180608779, M180608782, M180608783, M180608784, M180608785, M180608786, M180608787, M180608788, M180608789, M180608790, M180608792, M180608793, M180608794, M180608795, M180608796, M180608797, M180608798, M180608800, M180608802, M180608803, M180608804, M180608805, M180608807, M180608808, M180608809, M180608810, M180608811, M180608812, M180608813, M180608815, M180708816, M180708819, M180708820, M180708821, M180708822, M180708827, M180808831, M180808833, M180808834, M180808836, M180808843, M180808851, M180808852, M180808853, M180808854, M181008860, M181008861, M181008862, M181008863, M181008865, M181008866, M181008867, M181008868, M181008872, M181008873, M181008874, M181008875, M181008876, M181008877, M181008878, M181008882, M181008883, M181008884, M181008885, M181008887, M181008888, M181008889, M181008890, M181008891, M181008892, M181008893, M181008894, M181008895, M181008896, M181008897, M181008898, M181008899, M181108904, M181108905, M181108907, M181108908, M181108910, M181108912, M181108913, M181208914, M181208916, M181208917, M181208918, M181208919, M181208920, M181208921, M181208922, M181208923, M181208924, M190108925, M190108927, M190108929, M190108930, M190108931, M190108933, M190108934, M190108935, M190108936, M190108956, M190208964, M190208965, M190208966, M190208967, M190208968, M190208969, M190208970, M190208971, M190208972, M190208973, M190208974, M190208975, M190208987, M190208988, M190208989, M190208990, M190208992, M190208993, M190208994, M190208995, M190208996, M190300005, M190300006, M190300007, M190300008, M190300009, M190300010, M190300011, M190300014, M190300015, M190300016, M190300017, M190300018, M190300019, M190400005, M190400006, M190400007, M190400008, M190400010, M190500019, M190500042, M190500043, M190500052, M190600005, M190700001, M190700002, M190700003, M190700004, M190700005, M190800008, M190800009, M190800011, M190800012, M190800013, M190800014, M190800015, M190800016, M190800017, M190800018, M190800027, M190800028, M190800029, M190800030, M190800031, M190900001, M190900002, M190900005, M190900024, M190900025, M190900026, M190900028, M190900032, M190900034, M190900035, M191000001, M191000003, M191000004, M191000005, M191000006, M191000007, M191000008, M191000009, M191000010, M191000011, M191100008, M191100009, M191100010, M191100011, M191200001, M191200002, M191200003, M191200004, M191200005, M200100001, M200100003, M200100004, M200100005, M200100006, M200100007, M200200001, M200200002, M200200003, M200200004, M200200009, M200300001, M200300006, M200300009, M200400001, M200400002, M200400004, M200400005, M200400017, M200400018, M200400019, M200400023, M200400024, M200500002, M200500003, M200500004, M200500005, M200500006, M200500007, M200500008, M200500009, M200500010, M200600001, M200600002, M200600003, M200600004, M200600005, M200600006, M200600007, M200600008, M200600011, M200600012, M200600013, M200600015, M200600017, M200600020, M200600021, M200600022, M200600023, M200700001, M200700007, M200700015, M200700026, M200700027, M200700028, M200700029, M200700030, M200700031, M200700032, M200800001, M200800002, M200800003, M200800004, M200800005, M200800006, M200800007, M200800008, M200800009, M200800010, M200800011, M200800012, M200800013, M200800014, M200800015, M200800016, M200800017, M200900001, M200900002, M200900003, M200900004, M200900005, M200900006, M200900007, M200900008, M200900009, M200900010, M200900011, M200900012, M200900013, M200900014, M200900015, M200900016, M200900017, M200900018, M200900019, M200900020, M200900021, M201000003, M201000004, M201000005, M201000006, M201000007, M201000008, M201000009, M201000010, M201000011, M201000012, M201000013, M201000015, M201000018, M201000019, M201000020, M201000021, M201100001, M201100002, M201100003, M201100004, M201100005, M201100006, M201100007, M201100008, M201100059, M201100060, M201100062, M201100063, M201100064, M201100065, M201100066, M201100067, M201100068, M201200001, M201200002, M201200003, M201200005, M201200006, M210100001, M210100002, M210100003, M210100005, M210100006, M210100007, M210100008, M210100010, M210100011, M210100012, M210100013, M210100014, M210100015, M210100016, M210100017, M210100019, M210100020, M210100021, M210200001, M210200002, M210200003, M210200004, M210200005, M210200006, M210200007, M210200008, M210200009, M210200010, M210200012, M210200013, M210200014, M210200015, M210200016, M210200017, M210200018, M210200019, M210200025, M210200030, M210200031, M210200032, M210200033, M210200034, M210200035, M210300003, M210300004, M210300005, M210300006, M210300007, M210300009, M210300010, M210300011, M210300012, M210300013, M210300015, M210300016, M210300018, M210300019, M210300020, M210300022, M210300023, M210300024, M210300025, M210400007, M210400008, M210400009, M210400010, M210400011, M210400012, M210400013, M210400014, M210400015, M210400027, M210400028, M210400029, M210400030, M210400031, M210400032, M210400033, M210400034, M210400035, M210400036, M210400037, M210400038, M210400039, M210400040, M210400041, M210400042, M210400043, M210400044, M210400045, M210400046, M210400047, M210400048, M210400049, M210400050, M210500001, M210500003, M210500004, M210500005, M210500006, M210500007, M210500008, M210500009, M210500010, M210500011, M210500012, M210500013, M210500014, M210500015, M210500016, M210500017, M210500018, M210500019, M210500020, M210500021, M210500022, M210500023, M210500024, M210500025, M210500026, M210500027, M210500028, M210500029, M210500030, M210500031, M210500032, M210500033, M210500034, M210500036, M210500037, M210500039, M210500040, M210500041, M210800002, M210800003, M210800005, M210800006, M210800007, M210800008, M210800009, M210800010, M210800011, M210800012, M210800013, M210800014, M210800015, M210800016, M210800017, M210800019, M210800020, M210800021, M210800022, M210800023, M210800024, M210800025, M210800026, M210800027, M210800028, M210800029, M210800030, M210800031, M210800032, M210800033, M210900001, M210900003, M210900004, M210900005, M210900006, M210900007, M210900008, M210900010, M210900011, M210900012, M210900013, M210900014, M210900015, M210900016, M210900017, M210900018, M210900019, M210900020, M210900021, M210900022, M210900023, M210900024, M210900025, M211000001, M211000003, M211000004, M211000005, M211000007, M211000008, M211000009, M211000010, M211000011, M211000012, M211000013, M211000014, M211200001, M211200002, M211200003, M211200004, M211200005, M140600524, M140700798, M140700803, M140800826, M140800866, M140901181, M140901183, M141201855, M141201864, M150202510, M150202513, M150402908, M150402910, M150402933, M150503406, M150503408, M150503425, M150905423, M151005977, M151005980, M151005981, M151005982, M151005984, M151005985, M151005986, M151005987, M151005991, M151005992, M151005993, M151206552, M151206557, M160307208, M160307222, M160307225, M160307231, M160307235, M160707618, M160707619, M160707621, M160707622, M160707631, M160707632, M160707633, M160707636, M161208051, M170108105, M170608276, M170608278, M170608279, M170608280, M170608281, M170608283, M170608284, M170608288, M170608291, M170608292, M170608299, M170608300, M170608304, M170608306, M170608307, M170708322, M170808330, M170808331, M170808332, M170808333, M170808334, M170808335, M170808348, M170808349, M170808350, M170808351, M171108405, M171108435, M180208513, M180308522, M180308524, M180308528, M180308530, M180308531, M180308532, M180308533, M180308534, M180408558, M180408559, M180408560, M180408561, M180408592, M180508594, M180508595, M180508613, M180508614, M180508615, M180508622, M180508623, M180508624, M180608640, M180608664, M180608665, M180608666, M180608675, M180608676, M180608685, M180608686, M180608704, M180608705, M180608706, M180608715, M180608716, M180708824, M180708825, M180708826, M180808828, M180808829, M180808838, M180808839, M180808842, M180808844, M180808846, M180808847, M180808848, M180808849, M180808850, M180908856, M180908858, M180908859, M181008869, M181008879, M181008880, M181008901, M181008902, M181008903, M190108937, M190108938, M190108939, M190108940, M190108941, M190108942, M190108943, M190108945, M190108947, M190108948, M190108949, M190108950, M190108951, M190108952, M190108953, M190108954, M190300001, M190300003, M190300004, M190400001, M190400003, M190400004, M190500001, M190500002, M190500003, M190500004, M190500005, M190500006, M190500007, M190500008, M190500009, M190500016, M190500017, M190500018, M190500021, M190500022, M190500044, M190500045, M190500046, M190500047, M190500048, M190500049, M190500050, M190500051, M190600001, M190600002, M190600006, M190600007, M190600008, M190600009, M190600010, M190600011, M190600012, M190600013, M190600014, M190600015, M190600017, M190600018, M190600019, M190600020, M190600021, M190600023, M190600026, M190600027, M190600028, M190600029, M190700006, M190700007, M190700008, M190700009, M190700010, M190700011, M190700012, M190700013, M190700014, M190700015, M190700016, M190700017, M190700018, M190700019, M190700020, M190700021, M190700022, M190700023, M190700024, M190700025, M190700026, M190700027, M190700029, M190700030, M190700031, M190700032, M190700033, M190700034, M190700035, M190700036, M190800002, M190800003, M190800004, M190800005, M190800006, M190800007, M190800019, M190800020, M190800021, M190800022, M190800023, M190800024, M190800025, M190800026, M190900039, M190900041, M200700002, M200700003, M200700004, M200700005, M200700006, M200700008, M200700009, M200700010, M200700011, M200700012, M200700013, M200700014, M200700016, M200700017, M200700018, M200700019, M200700020, M200700021, M200700022, M200700024, M200700025, M210200020, M210200021, M210200022, M210200023, M210200024, M210200026, M210200027, M210200028, M210200029, M210200038, M210200039, M210300001, M210300002, M210300014, M210300017, M210400001, M210400002, M210400003, M210400004, M210400006, M210400018, M210400019, M210400020, M210400021, M210400022, M210400023, M210400025, M210400026, M210500042, M210500043, M210600001, M210600002, M210600003, M210600004, M210600005, M210600006, M210600007, M210800035, M210800036, M210800037, M210800038, M210800039, M210800040, M210800041, M210800042, M210800043, M210800044, M210800045, M210800046, M211000023, M211000024, M211000025, M220600002, M220600003, M220600004, M220600005, M220600006, M220600008, M220600011, M220600034, M220600036, M220600037, M220600038, M220600039, M220600040, M220600041, M220600042, M220700189, M220700192, M161208048

Other Recalls from St. Jude Medical

Recall # Classification Product Date
Z-1427-2025 Class II CardioMEMS Heart Failure (HF) System that consi... Feb 3, 2025
Z-0987-2025 Class II Merlin.net Patient Care Network (PCN) Heart Fai... Nov 6, 2024
Z-0988-2025 Class II CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Card... Oct 5, 2024
Z-0989-2025 Class II CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Card... Oct 5, 2024
Z-2348-2024 Class II St. Jude Medical Agilis NxT Steerable Introduce... Apr 30, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from St. Jude Medical Recalls by Firm Recall Reasons Device Safety Stats