Boston Scientific Corporation: TENACIO Pump without InhibiZone; UPN: 72404420;
Read the official notice at FDA (device) →
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Boston Scientific Corporation
- Product
- TENACIO Pump without InhibiZone; UPN: 72404420;
- Reason / hazard
- The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2025-09-11
- Code info
- UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;
- Product quantity
- 0 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Marlborough
- State
- MA
- Country
- United States
- Event id
- 97603
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