FDA Device recall Z-0141-2026
LGX Preconnect with TENACIO Pump without InhibiZone
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of LGX Preconnect with TENACIO Pump without InhibiZone by Boston Scientific, citing the potential for devices to experience inflation and/or deflation performance issues or difficulties.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0141-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-11 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Reason
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Identifiers
| code_info | 1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UD…1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0141-2026%22
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