Z-0141-2026 Class II Ongoing

Recalled by Boston Scientific Corporation — Marlborough, MA

Recall Details

Product Type
Devices
Report Date
October 22, 2025
Initiation Date
September 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0 units

Product Description

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

Reason for Recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895;