FDAHealthSeptember 11, 2025
Boston Scientific Corporation — LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
⚠️ 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
- LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
- Lot code
- 1100687060
Additional details
1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 0 units.
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