FDA Medical devices recall ·
LGX Preconnect with TENACIO Pump with InhibiZone recall
- Recall number
- Z-0144-2026
- Date
- (initiated September 11, 2025)
- Company / brand
- Boston Scientific Corporation
100 Boston Scientific Way, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 490 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
Why was it recalled?
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. UPN: 72404450 (12CM PS IZ); UDI-DI: 00191506021412; Lot numbers: 1100404813, 1100404817, 1100404818, 1100404819, 1100404820, 1100404821, 1100558512, 1100565086, 1100568924, 1100585061, 1100596471, 1100596473, 1100617027, 1100404816, 1100404814, 1100404815, 1100558509, 1100512315, 1100565093, 1100512387, 1100565088, 1100558508, 1100512313, 1100512388, 1100565084, 1100568927, 1100568926, 1100611812, 1100585059, 1100596478, 1100598982, 1100611809, 1100596324, 1100596477, 1100596472, 1100579740, 1100585066, 1100585064, 1100579739, 1100619111, 1100626304, 1100611810, 2. UPN: 72404451 (15CM PS IZ); UDI-DI: 00191506021429; Lot numbers: 1100480113, 1100480114, 1100480115, 1100480117, 1100480622, 1100480623, 1100480624, 1100480625, 1100480626, 1100480627, 1100480628, 1100511666, 1100511668, 1100511669, 1100511671, 1100511673, 1100558263, 1100558264, 1100558265, 1100563672, 1100563673, 1100563674, 1100563676, 1100563679, 1100563680, 1100584476, 1100584477, 1100584479, 1100584481, 1100584482, 1100584483, 1100592722, 1100592723, 1100592724, 1100592725, 1100592726, 1100592728, 1100595757, 1100595758, 1100595762, 1100595763, 1100595764, 1100595785, 1100595786, 1100595787, 1100595788, 1100609511, 1100609512, 1100609514, 1100613865, 1100613869, 1100613870, 1100613871, 1100613872, 1100613873, 1100614058, 1100614059, 1100614061, 1100614062, 1100614063, 1100614064, 1100614065, 1100615565, 1100615568, 1100615571, 1100615572, 1100615573, 1100636975, 1100636981, 1100636982, 1100636983, 11006560
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0144-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.