The Recall Desk
Severity pendingFDA (Devices)·Z-0141-2026·Announced 2025-10-22

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

Pending LLM rewrite. Source: FDA_DEVICE Z-0141-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.