TENACIO Pump with InhibiZone; UPN: 72404429;
Pending LLM rewrite. Source: FDA_DEVICE Z-0138-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The recalled product
- Product
- TENACIO Pump with InhibiZone; UPN: 72404429;
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Devices
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)
- UPN: 72404429
- UDI-DI: Lot numbers: 1100551131
- 1100551132
- 1100551134
- 1100551135
- 1100551136
- 1100551137
- 1100551139
- 1100551145
- 1100551149
- 1100553579
- 1100553580
- 1100553582
- 1100553583
- 1100553584
- 1100553585
- 1100553586
- 1100553588
- 1100553589
- 1100553590
Distribution
Distributed nationwide across the United States.
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