FDAHealthSeptember 11, 2025
Boston Scientific Corporation — TENACIO Pump without InhibiZone; UPN: 72404420;
⚠️ The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 11, 2025
Worldwide distribution - US Nationwide and the country of Canada.
What's affected?
- Product
- TENACIO Pump without InhibiZone; UPN: 72404420;
- Lot code
- 1100720566
Additional details
UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 0 units.
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