TENACIO Pump without InhibiZone; UPN: 72404420;
Pending LLM rewrite. Source: FDA_DEVICE Z-0139-2026.
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 without InhibiZone; UPN: 72404420;
- 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 (4)
- UPN: 72404420
- UDI-DI: Lot numbers: 1100720566
- 1100720567
- 1100720568
Distribution
Distributed nationwide across the United States.
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