CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 7240...
FDA Recall #Z-0143-2026 — Class II — September 11, 2025
Product Description
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);
Reason for Recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
172 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ); UDI-DI: 00191506021511; Lot numbers: 1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714, 1100605715, 1100609592, 1100613514, 1100621453, 1100621454, 1100625387, 1100625388, 1100625391, 1100522433, 1100489493, 1100489492, 1100489495, 1100543858, 1100489546, 1100489494, 1100489496, 1100543859, 1100543864, 1100489497, 1100625392, 1100625394, 1100613511, 1100605718, 1100625393, 1100602694, 1100599203, 1100609585, 1100602695, 1100605709, 1100605710, 1100602564, 1100599196, 1100677511, 1100677506, 1100677507, 1100677509, 1100715069, 3. UPN: 72404463 (16CM PS IZ); UDI-DI: 00191506021528; Lot numbers: 1100480549, 1100480555, 1100480559, 1100480561, 1100480562, 1100480567, 1100492188, 1100511647, 1100511648, 1100511652, 1100511653, 1100511654, 1100511655, 1100511705, 1100511711, 1100546879, 1100546880, 1100546881, 1100551274, 1100551275, 1100551276, 1100551280, 1100560945, 1100560950, 1100565155, 1100565156, 1100565163, 1100565574, 1100565578, 1100565579, 1100565580, 1100565629, 1100565632, 1100565634, 1100565635, 1100602136, 1100602140, 1100602194, 1100602195, 1100602197, 1100602227, 1100602228, 1100602229, 1100605207, 1100605211, 1100605214, 1100614920, 1100615585, 1100615587, 1100619169, 1100619173, 1100619174, 1100657322, 1100657324, 1100657325, 1100511649, 1100565159, 1100511709, 1100560952, 1100480550, 1100480568, 1100565581, 1100492184, 1100546878, 1100546876, 1100546877, 1100546875, 1100480557, 1100511650, 1100511704, 1100480553, 1100480552, 1100480558, 1100480551, 1100511702, 1100511651, 1100511703, 1100480556, 1100565631, 1100560953, 1100605206, 1100602225, 1100602196, 1100614923, 1100602192, 1100602223, 1100606735, 1100615594, 1100615588, 1100614926, 1100619170, 1100615590, 1100615589, 1100602193, 1100602199, 1100602201, 1100605210, 1100690401, 1100657331, 1100657330, 1100663408, 1100663399, 1100657326, 4. UPN: 72404464 (18CM PS IZ); UDI-DI: 00191506021535; Lot numbers: 1100591058, 1100591064, 1100591059, 5. UPN: 72404465 (10CM IP IZ); UDI-DI: 00191506021542; Lot numbers: 1100590252, 1100557278, 6. UPN: 72404466 (12CM IP IZ); UDI-DI: 00191506021559; Lot numbers: 1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540, 1100398541, 1100398542, 1100556794, 1100491464, 1100491466, 1100573736, 1100491465, 1100573773, 1100491472, 1100565103, 1100573739, 1100512182, 1100554190, 1100512180, 1100491470, 1100491471, 1100491467, 1100512183, 1100554188, 1100556786, 1100573737, 1100573738, 1100491463, 1100573774, 1100512181, 1100573732, 1100491469, 1100573730, 1100491468, 1100554187, 1100627360, 1100627357, 1100627355, 1100668336, 1100668329, 1100668337, 7. UPN: 72404467 (14CM IP IZ); UDI-DI: 00191506021566; Lot numbers: 1100492102, 1100554145, 1100569162, 1100569187, 1100574563, 1100585072, 1100626261, 1100512197, 1100554148, 1100492110, 1100512198, 1100569181, 1100572069, 1100569180, 1100556843, 1100554150, 1100569165, 1100556842, 1100492104, 1100574559, 1100569179, 1100569161, 1100554146, 1100492103, 1100512202, 1100512196, 1100574566, 1100572068, 1100569159, 1100556839, 1100512201, 1100569184, 1100626262, 1100585076, 1100626260, 8. UPN: 72404468 (16CM IP IZ); UDI-DI: 00191506021573; Lot numbers: 1100524763, 1100524766, 1100554179, 1100554180, 1100560191, 1100560905, 1100560907, 1100569608, 1100569612, 1100569649, 1100569656, 1100573275, 1100574054, 1100574055, 1100574058, 1100574059, 1100574062, 1100624980, 1100624983, 1100624987, 1100624988, 1100626293, 1100626296, 1100554173, 1100560903, 1100524760, 1100573278, 1100569609, 1100490867, 1100569610, 1100524761, 1100560908, 1100554175, 1100560197, 1100574056, 1100569605, 1100554177, 1100574057, 1100574060, 1100490863, 1100560900, 1100569648, 1100573273, 1100573269, 1100569604, 1100560906, 1100569657, 1100524758, 1100626288, 1100626295, 1100626292, 9. UPN: 72404469 (18CM IP IZ); UDI-DI: 00191506021580; Lot numbers: 1100624977, 1100624974, 1100624975, 1100624978, 1100624969, 1100624976, 1100624970, 1100624973,
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.