The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Program...

FDA Device Recall #Z-1669-2022 — Class II — July 7, 2022

Recall Summary

Recall Number Z-1669-2022
Classification Class II — Moderate risk
Date Initiated July 7, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Boston Scientific Corporation
Location Saint Paul, MN
Product Type Devices
Quantity 17,172 units in total

Product Description

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

Reason for Recall

There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

Distribution Pattern

Worldwide Distribution

Lot / Code Information

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070634, 070650, 070665, 070672, 070695, 070712, 070713, 070737, 070738, 070741, 070742, 070744, 070757, 070760, 070761, 070795, 070805, 070811, 070825, 070830, 070841, 070850, 070859, 070876, 070891, 070919, 070931, 070954, 070961, 071002, 071006, 071038, 071039, 071042, 071047, 071049, 071098, 071105, 071114, 071118, 071127, 071134, 071154, 071164, 071169, 071170, 071171, 071179, 071181, 071191, 071199, 071201, 071203, 071205, 071216, 071225, 071229, 071234, 071236, 071258, 071262, 071269, 071300, 071314, 071488, 071508, 071513, 071526, 071527, 071536, 071538, 071551, 071584, 071589, 071595, 071608, 071614, 071618, 071628, 071639, 071645, 071651, 071668, 071670, 071677, 071689, 071691, 071693, 071695, 071706, 071710, 071721, 071729, 071743, 071761, 071777, 071791, 071794, 071795, 071818, 071825, 071836, 071963, 071967, 071978, 071979, 071990, 071991, 071999, 072017, 072023, 072035, 072057, 072060, 072063, 072068, 072083, 072102, 072397, 072454, 072503; UPN 00802526456961, Serial Numbers: 051625, 051843, 054959, 055034, 055550, 055680, 055681, 055976, 056616, 056639, 056915, 056919, 057173, 057281, 057950, 058471, 058818, 058850, 058990, 059407, 060062, 060458, 060570, 062013, 062405, 062433, 062443, 062549, 063614, 064043, 064139, 064353, 065088, 066639, 066674, 066687, 066815, 066835, 066852, 066869, 066880, 066885, 066898, 066953, 066999, 067022, 067466, 067494, 067615, 067642, 067769, 068196, 068306, 068327, 068479, 068704, 068821, 068830, 068857, 069067, 069085, 069086, 069129, 069216, 069272, 069301, 069332, 069571, 070267, 070282, 070286, 070636, 070658, 070674, 070687, 070692, 070699, 070702, 070703, 070708, 070767, 070786, 070801, 070807, 070821, 070842, 070870, 070877, 070908, 070910, 070918, 070922, 070924, 070944, 070952, 070953, 070959, 070970, 070972, 070976, 070984, 071057, 071062, 071067, 071077, 071092, 071121, 071128, 071133, 071136, 072496, 073187, 073190, 073193, 073210, 073233, 073234, 073248, 073254, 073257, 073258, 073290, 073293, 073304, 073355, 073359, 073374, 073383, 073385, 073387, 073395, 073401, 073422, 073435, 073446, 073448, 073453, 073473, 073476, 073481; UPN 00802526467653, Serial Numbers: 051130, 051136, 051571, 051610, 051628, 051639, 051644, 051756, 051772, 051890, 055100, 055118, 055177, 055218, 055244, 055301, 055334, 055370, 055482, 055506, 055511, 055540, 055839, 055922, 055939, 056418, 056478, 056527, 056853, 057025, 057097, 057448, 057674, 057747, 057810, 057842, 057930, 058079, 058096, 058197, 058234, 058336, 058521, 058827, 059036, 059231, 059349, 059536, 059881, 059992, 060135, 060488, 060815, 060888, 060929, 060935, 060981, 061999, 062210, 062296, 062302, 062494, 062495, 062557, 062584, 063766, 063806, 063899, 064226, 064253, 064744, 064761, 064823, 065004, 065023, 065447, 065514, 065596, 065687, 066057, 066068, 066648, 066909, 067049, 067373, 067406, 067462, 067687, 067745, 068266, 068346, 068503, 068521, 068574, 068604, 068610, 068713, 068744, 068757, 068808, 068823, 068976, 068990, 069034, 069182, 069184, 069281, 069284, 069292, 069550, 070340, 070397, 070565, 070606, 070727, 070734, 070792, 070826, 070831, 070868, 070872, 070879, 070916, 070927, 070962, 071150, 071316, 071318, 071454, 071459, 071469, 071470, 071472, 071481, 071591, 071758, 071774, 071798, 071823, 071965, 071985, 071995, 072501, 073191, 073204, 073252, 073302, 073348, 073372, 073421, 073424, 073426, 073449, 073451, 073483, 073484, 073488, 073494, 073495, 073506, 073515, 073523, 073530, 073531, 073542, 073544, 073551, 073562, 073564, 073566, 073570, 073577, 073582, 073596, 073602, 073603, 073614; UPN 00802526468582, Serial Numbers: 051049, 051125, 051160, 051443, 051651, 051761, 052121, 052349, 054975, 055212, 055352, 055512, 055588, 055678, 055724, 055769, 055837, 055984, 056275, 056314, 056388, 056509, 056525, 056563, 056912, 056934, 057014, 057070, 057111, 057187, 057418, 057459, 057491, 057546, 057661, 057774, 057792, 057960, 057987, 058131, 058678, 058788, 058859, 058924, 058941, 058969, 059043, 059138, 059182, 059222, 059239, 059465, 059520, 059843, 059931, 059934, 059965, 060082, 060249, 060470, 060487, 060498, 060936, 061010, 061070, 061969, 061998, 062038, 062233, 062279, 063475, 064344, 064376, 064712, 064780, 065055, 065096, 065154, 065268, 065371, 065452, 065962, 066511, 066830, 066941, 067387, 067477, 067501, 067520, 067583, 067625, 067630, 067697, 067726, 067742, 067753, 067757, 067762, 067766, 067783, 067807, 067809, 068272, 068519, 068525, 068553, 068629, 068737, 068800, 068902, 068957, 068964, 069004, 069058, 069190, 069291, 069295, 069457, 069831, 070380, 070619, 070630, 070763, 070955, 070991, 071045, 071528, 071545, 071575, 071621, 071626, 071684, 071762, 071767, 071775, 071982, 072042, 072069, 072098, 072113, 072114, 072157, 072291, 072330, 072358, 072359, 072365, 072412, 072419, 072428, 072465, 073213, 073282; UPN 00802526473449, Serial Numbers: 051361, 051608, 051749, 055029, 055114, 055194, 055489, 055642, 055847, 055903, 056028, 056067, 056142, 056181, 056241, 056362, 056397, 056789, 056882, 057844, 057926, 058373, 058395, 059020, 059241, 059290, 059301, 059616, 059935, 060198, 061859, 062097, 064167, 064220, 064825, 064843, 064848, 065032, 065107, 065472, 065565, 066638, 066799, 066847, 066943, 066947, 067014, 067451, 067578, 067651, 067828, 068213, 068258, 068303, 068315, 068316, 068484, 068532, 068663, 069053, 069175, 069179, 069181, 069183, 069193, 069317, 069329, 069544, 069665, 069787, 069884, 070305, 070764, 070979, 071180, 071257, 071267, 071296, 071491, 071507, 071519, 071636, 071641, 072033, 073321, 073556; UPN 00802526474859, Serial Numbers: 051572, 051601, 051671, 051844, 051958, 055051, 055076, 055259, 055451, 055536, 055563, 055656, 055682, 055698, 055722, 055883, 055910, 056259, 056734, 056746, 056791, 056929, 056946, 056962, 057314, 057379, 057445, 058088, 058760, 058934, 060021, 060065, 060188, 060353, 060469, 060626, 060630, 062066, 062185, 062248, 062463, 063486, 063573, 064092, 064127, 064231, 064361, 064374, 064463, 064680, 064728, 064857, 065616, 065713, 065766, 066013, 066758, 066936, 067437, 067664, 068580, 068723, 069242, 069258, 069336, 069439, 070249, 070312, 070566, 070627, 070806, 070917, 071095, 071167, 071311, 071313, 071319, 071563, 072455, 073389, 073444, 073572, 073608; UPN 00802526475788, Serial Numbers: 051424, 051509, 051804, 051815, 051928, 052015, 055153, 055159, 055232, 055315, 055401, 055475, 055998, 056016, 056326, 056343, 056361, 056375, 056475, 056488, 056606, 056613, 056854, 056955, 056982, 057034, 057051, 057076, 057178, 057185, 057275, 057324, 057545, 057652, 057772, 057804, 057851, 057865, 057870, 057943, 058142, 058325, 058352, 058523, 058555, 058732, 059015, 059294, 059378, 059387, 059488, 059551, 059595, 059633, 059634, 059641, 059785, 059838, 059884, 059954, 059955, 060035, 060125, 060137, 060248, 060305, 060346, 060373, 060408, 060600, 060695, 060726, 060777, 060862, 061827, 061875, 061910, 061950, 062000, 062219, 062293, 062475, 062480, 062540, 063462, 063629, 063636, 063758, 064278, 064512, 064543, 064561, 064563, 064633, 064903, 064915, 064931, 065132, 065151, 065174, 065202, 065227, 065236, 065378, 065436, 065552, 065740, 066074, 066630, 066634, 066920, 067026, 067050, 067435, 067781, 067820, 068338, 068550, 068671, 068743, 068949, 069006, 069030, 069062, 069176, 069244, 069319, 069547, 069608, 069625, 069643, 069741, 070275, 070367, 070416, 070676, 070808, 070869, 070884, 070892, 070990, 071005, 071276, 071460, 071498, 071534, 071625, 071660, 071701, 071726, 071968, 072000, 072105, 072132, 072134, 073194, 073209, 073312, 073313, 073316, 073397, 073408, 073431, 073454, 073459; UPN 00802526477676, Serial Numbers: 051616, 056600, 057919, 062305, 063553, 064509, 064522, 067524, 067758, 070864; UPN 00802526478239, Serial Numbers: 051214, 051888, 055183, 055291, 055624, 055807, 055892, 055926, 055980, 056201, 056495, 056504, 056626, 056684, 057023, 057127, 057182, 057213, 057354, 057424, 057593, 057715, 057751, 058012, 058207, 058235, 058255, 058277, 058507, 058829, 059050, 059056, 059297, 059298, 059399, 059690, 059856, 059871, 059909, 059996, 060221, 060610, 060772, 060825, 060893, 060976, 061062, 061900, 062166, 062323, 062324, 062451, 063709, 064140, 064165, 064327, 064644, 064751, 064772, 064891, 064900, 064928, 065015, 065185, 065323, 065372, 065650, 066016, 066028, 066061, 066850, 067629, 068232, 068286, 068561, 068571, 068682, 068763, 069348, 069436, 069531, 069593, 069612, 069617, 069621, 069628, 069634, 069638, 069679, 070300, 070797, 071046, 071075, 071086, 071455, 071680, 071802, 072046, 072072, 072131, 072156, 072299, 072390, 072464, 073333; UPN 00802526479663, Serial Numbers: 051024, 051642, 051716, 052009, 055047, 055096, 055138, 055364, 055428, 055606, 055716, 055785, 056012, 056064, 056633, 056719, 056911, 057130, 057489, 057528, 057706, 057762, 057777, 057831, 058064, 058251, 058264, 058306, 058315, 058598, 058759, 059058, 059259, 059382, 059430, 059485, 059517, 059626, 059761, 060060, 060102, 060308, 060318, 060338, 060363, 060369, 060395, 060576, 060622, 062333, 064686, 064787, 065134, 065148, 065235, 065660, 065748, 065977, 065995, 066777, 066958, 067515, 067547, 067568, 067623, 067684, 067718, 068345, 068942, 069008, 069028, 069031, 069298, 069438, 069556, 069647, 069839, 069850, 070784, 070833, 070934, 071266, 071480, 071578, 071617, 072008, 072081, 072094, 072500, 073219, 073318, 073413, 073597; UPN 00802526480638, Serial Numbers: 051101, 051334, 051401, 051461, 051591, 051622, 051723, 051762, 051811, 051822, 055064, 055141, 055144, 055234, 055303, 055339, 055483, 055490, 055518, 055582, 055614, 055628, 055705, 055979, 056042, 056047, 056079, 056285, 056396, 056443, 056750, 056767, 056880, 056932, 056973, 057045, 057086, 057198, 057506, 057554, 057628, 057761, 057830, 057935, 057959, 058153, 058287, 058361, 058384, 058386, 058405, 058543, 058635, 058683, 058686, 059021, 059053, 059152, 059173, 059292, 059328, 059370, 059374, 059499, 059526, 059614, 059733, 059786, 059806, 059821, 059916, 060010, 060070, 060133, 060181, 060192, 060247, 060539, 060552, 060644, 060729, 060822, 060883, 060932, 061043, 061830, 061867, 061955, 062055, 062113, 062188, 062243, 062303, 062412, 062420, 062524, 063603, 063656, 063696, 063729, 063745, 063794, 063821, 063959, 064169, 064222, 064241, 064277, 064297, 064328, 064412, 064525, 064665, 064953, 064964, 064978, 065161, 065167, 065168, 065218, 065281, 065285, 065293, 065317, 065352, 065510, 065518, 065629, 065966, 066101, 066629, 066650, 066858, 066888, 066955, 066972, 066977, 067063, 067425, 067469, 067476, 067525, 067658, 067700, 068295, 068319, 068524, 068587, 068605, 068677, 068844, 068956, 069011, 069148, 069188, 069197, 069271, 069293, 069309, 069313, 069341, 069395, 069467, 069468, 069530, 069598, 069790, 069844, 069853, 069865, 070289, 070303, 070317, 070618, 070704, 070771, 070794, 070974, 071026, 071044, 071123, 071126, 071158, 071194, 071281, 071506, 071632, 071642, 071813, 072050, 072074, 072399, 072457, 072484, 073255, 073272, 073375, 073390, 073436, 073442, 073558, 073565, 074370, 074372, 074380, 074395, 074415, 074467, 074537, 074538, 074548, 074550, 074554, 074559, 074560, 074562, 074565, 074570, 074573, 074583, 074587, 074588, 074590, 074597, 074605, 074606, 074613, 074614, 074615, 074617, 074624, 074628, 074629, 074646, 074650, 074662, 074664, 074668, 074670, 074678, 074697, 074700, 074702, 074730, 074818, 074825, 074839, 074840, 074853, 074866, 074872, 074874, 074877, 074879, 074888, 074896, 074902, 074909, 074911, 074942, 074947, 074959, 074963, 074965, 074968, 074974; UPN 00802526484599, Serial Numbers: 074986, 074988, 074991, 074992, 074995, 075001, 075004, 075006, 075007, 075014, 075016, 075017, 075028, 075031, 075034, 075042, 075045, 075046, 075050, 075057, 075060, 075062, 075064, 075069, 075070, 075084, 075093, 075097, 075102, 075106, 075112, 075113, 075121, 075133, 075141, 075142, 075149, 075152, 075153, 075162, 075165, 075166, 075172, 075177, 075192, 075196, 075199, 075200, 075203, 075204, 075205, 075218, 075221, 075222, 075223, 075227, 075230, 075242, 075245, 075246, 075247, 075252, 075253, 075255, 075256, 075257, 075270, 075272, 075281, 075285, 075288, 075289, 075290, 075292, 075295, 075300, 075310, 075313, 075316, 075320, 075323, 075325, 075327, 075329, 075331, 075333, 075342, 075345, 075348, 075352, 075357, 075361, 075370, 075371, 075388, 075390, 075391, 075396, 075408, 075411, 075414, 075415, 075416, 075419, 075425, 075429, 075432, 075445, 075457, 075458, 075462, 075469, 075471, 075477, 075478, 075479, 075482, 075483, 075514, 075516, 075522, 075534, 075548, 075554, 075559, 075567, 075574, 075581, 075584, 075596, 075601, 075609, 075613, 075617, 075626, 075627, 075633, 075637, 075661, 075671, 075680, 075688, 075689, 075693, 075696, 075702, 075710, 075717, 075719, 075720, 075723, 075737, 075751, 075763, 075768, 075778, 075781, 075785, 075801, 075806, 075812, 075846, 075858, 075990, 075993, 076010, 076021, 076060, 076061, 076100; UPN 00802526486906, Serial Numbers: 051057, 051105, 051247, 051394, 051441, 051603, 051872, 052185, 054955, 054976, 054989, 055014, 055195, 055222, 055290, 055294, 055314, 055322, 055340, 055379, 055410, 055418, 055508, 055604, 055612, 055688, 055740, 055803, 056001, 056043, 056097, 056189, 056203, 056226, 056265, 056429, 056505, 056517, 056564, 056587, 056637, 056714, 056735, 056803, 056881, 056992, 057003, 057015, 057028, 057083, 057125, 057171, 057244, 057387, 057423, 057788, 057846, 057880, 057899, 057901, 057971, 058066, 058165, 058219, 058253, 058260, 058261, 058288, 058374, 058456, 058656, 058832, 058895, 058911, 058914, 058972, 058977, 058980, 059093, 059168, 059281, 059296, 059304, 059372, 059450, 059561, 059615, 059625, 059652, 059666, 059707, 059772, 059790, 059859, 059869, 059889, 059972, 060044, 060055, 060131, 060182, 060334, 060383, 060459, 060489, 060532, 060534, 060590, 060591, 060602, 060667, 060691, 060721, 060787, 060835, 060840, 060859, 060937, 061862, 061987, 062014, 062083, 062104, 062139, 062171, 062197, 062211, 062415, 062532, 063483, 063496, 063523, 063527, 063608, 063742, 063775, 063778, 063829, 063853, 063886, 063919, 064012, 064058, 064086, 064164, 064178, 064179, 064228, 064427, 064445, 064523, 064621, 064641, 064691, 064792, 064835, 064877, 064975, 065091, 065304, 065384, 065421, 065431, 065476, 065618, 065671, 065678, 065680, 065726, 065938, 066003, 066734, 066800, 066831, 067024, 067039, 067388, 067412, 067426, 067444, 067486, 067513, 067528, 067636, 068195, 068304, 068370, 068627, 068733, 068895, 068898, 069012, 069020, 069032, 069071, 069147, 069156, 069255, 069264, 069388, 069506, 069539, 069581, 069657, 069788, 069819, 070330, 070391, 070401, 070549, 070562, 070591, 070681, 070827, 070878, 070980, 071008, 071043, 071058, 071087, 071263, 071305, 071447, 071501, 071543, 071553, 071585, 071611, 071734, 072012, 072374, 073200, 073221, 073232, 073278, 073288, 073339, 073469, 073471, 074414, 074546, 074584, 074673, 074709, 074842, 074907, 074924, 074928, 074937, 074940, 074973, 075015, 075073, 075077, 075091, 075135, 075168, 075174, 075233, 075294, 075315, 075317, 075344, 075395, 075401, 075424, 075433, 075436, 075446, 075454, 075461, 075484, 075501, 075504, 075523, 075625, 075715, 075724, 075730, 075734, 075755, 075767, 075770, 075793, 075817, 075825, 075836, 075844, 075847, 075850, 075852, 075854, 075857, 075864, 075865, 075869, 075873, 075885, 075892, 075895, 075900, 075905, 075911, 075912, 075916, 075923, 075989, 075994, 076007, 076008, 076014, 076022, 076023, 076025, 076030, 076035, 076039, 076049, 076059, 076068, 076070, 076078, 076088, 076091, 076101, 076103, 076370, 076408, 076416, 076450, 076452, 076456, 076462, 076464, 076471, 076481, 076483, 076484, 076488, 076496, 076497, 076501, 076502, 076503, 076511, 076517, 076520, 076523, 076533, 076541, 076545, 076555, 076560, 076566, 076569, 076576, 076581, 076597, 076602, 076615, 076629, 076630, 076651, 076654, 076659, 076660, 076664, 076678, 076682, 076689, 076695, 076696, 076697, 076708, 076709, 076714, 076718, 076722, 076727, 076729, 076737, 076738, 076741, 076745, 076752, 076759, 076760, 076761, 076775, 076777, 076780, 076782, 076790, 076794, 076797, 076801, 076806, 076810, 076813, 076814, 076817, 076833, 076834, 076837, 076840, 076843, 076846, 076847, 076850, 076851, 076852, 076856, 076858, 076875, 076878, 076880, 076882, 076883, 076885, 076897, 076899, 076900, 076916, 076922, 076935, 076936, 076976, 076989, 076991, 077004, 077006, 077009, 077014, 077017, 077021, 077026, 077028, 077029, 077030, 077031, 077032, 077035, 077038, 077045, 077048, 077049, 077053, 077054, 077062, 077087, 077090, 077098, 077100, 077117, 077119, 077132, 077133, 077144, 077146, 077149, 077162, 077172, 077181, 077200, 077243; UPN 00802526494406, Serial Numbers: 051557, 051568, 051681, 051797, 055561, 055599, 055787, 056039, 056057, 056368, 056515, 056701, 056724, 056835, 056883, 057054, 057169, 057217, 057227, 057286, 057300, 057525, 057537, 057660, 057738, 057757, 058191, 058245, 058400, 058402, 058504, 058545, 058575, 058770, 058873, 059153, 059330, 059360, 059389, 059509, 059834, 059861, 059975, 060145, 060276, 060389, 060425, 060481, 060526, 060634, 060684, 060754, 060871, 060904, 061804, 061850, 061928, 061963, 061974, 062237, 062257, 062308, 062418, 062565, 063484, 063644, 063697, 063760, 063854, 063946, 063957, 064098, 064364, 064390, 064417, 064452, 064515, 064580, 064681, 064840, 065089, 065149, 065312, 065375, 065913, 066620, 066694, 066792, 066844, 067003, 067414, 067496, 067544, 067649, 067657, 067689, 067816, 068542, 068647, 068653, 068690, 068734, 068786, 068820, 068860, 068866, 068915, 068919, 068927, 069099, 069151, 069170, 069198, 069320, 069480, 069519, 069557, 069752, 069806, 070332, 070622, 070648, 070652, 070746, 070765, 070802, 070816, 070982, 071069, 071109, 071140, 071147, 071223, 071273, 071494, 071627, 071656, 072026, 072066, 072164, 072349, 072385, 073261, 073358, 073396, 073498, 073598, 074539, 074578, 074586, 074594, 074627, 074669, 074875, 074930, 074955, 074989, 075056, 075240, 075305, 075332, 075407, 075447, 075485, 075512, 075518, 075532, 075638, 075704, 075764, 075782, 075868, 076410, 076472, 076549, 076605, 077007, 077180, 077236; UPN 00802526497605, Serial Numbers: 051100, 051139, 051579, 051726, 051742, 051776, 051902, 051957, 052037, 052439, 055102, 055201, 055221, 055435, 055491, 055528, 055549, 055584, 055767, 055801, 055830, 055884, 055921, 055933, 056000, 056066, 056129, 056166, 056202, 056305, 056323, 056491, 056682, 056849, 056874, 057013, 057030, 057148, 057193, 057262, 057383, 057516, 057586, 057746, 057766, 057806, 057965, 057992, 058326, 058410, 058444, 058458, 058522, 058721, 058971, 059044, 059197, 059254, 059279, 059308, 059319, 059393, 059414, 059442, 059539, 059549, 059635, 059682, 059868, 059878, 059948, 059977, 060009, 060051, 060103, 060217, 060375, 060396, 060561, 060587, 060669, 060728, 060884, 061015, 061036, 061956, 061983, 061996, 062034, 062052, 062064, 062085, 062098, 062247, 062297, 062337, 062408, 063618, 063655, 063704, 063754, 063773, 063776, 063927, 063971, 063990, 064047, 064193, 064205, 064357, 064393, 064451, 064473, 064527, 064625, 064740, 065034, 065040, 065054, 065101, 065131, 065145, 065222, 065271, 065415, 065417, 065661, 065721, 065959, 066044, 066577, 066673, 066840, 066854, 066915, 066950, 067370, 067599, 067686, 067803, 068285, 068584, 068595, 068597, 068609, 068642, 068655, 068815, 068952, 069055, 069113, 069123, 069167, 069254, 069450, 069459, 069517, 069671, 069779, 069784, 069883, 070278, 070371, 070815, 070832, 070862, 070942, 071187, 071272, 071307, 07145

Other Recalls from Boston Scientific Corporation

Recall # Classification Product Date
Z-1551-2026 Class II EndoVive Safety PEG Kit; Outer Box Material Nu... Feb 10, 2026
Z-1160-2026 Class I AXIOS Stent and Electrocautery-Enhanced Deliver... Dec 19, 2025
Z-1162-2026 Class I *HOT AXIOS Stent and Electrocautery-Enhanced De... Dec 19, 2025
Z-1159-2026 Class I AXIOS Stent and Electrocautery-Enhanced Deliver... Dec 19, 2025
Z-1163-2026 Class I *HOT AXIOS Stent and Electrocautery-Enhanced De... Dec 19, 2025

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

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.