LGX Preconnect TENACIO Pump Devices Recalled for Inflation and Deflation Issues
Boston Scientific is recalling LGX Preconnect with TENACIO Pump devices that may experience inflation or deflation performance problems. Approximately 490 units were distributed to the US and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with potential performance malfunction issues, but no reported illnesses, injuries, or deaths. The hazard is theoretical without documented adverse events, placing it at the maximum score for precautionary recalls.
Plain-English summary
Boston Scientific Corporation is recalling LGX Preconnect with TENACIO Pump with InhibiZone devices due to the potential for inflation and/or deflation performance issues or difficulties.
The recall applies to eight device configurations in various sizes (12cm, 15cm, 18cm, and 21cm) available in both Percutaneous Subcutaneous and Intraperitoneal versions with InhibiZone technology. Approximately 490 units have been distributed to the United States and Canada. The recall is classified as FDA Class II and includes multiple specific lot numbers for each configuration.
The recalled product
- 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);
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- inflation-deflation-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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