FDA-Device2025-10-22Class II

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

Boston Scientific Corporation
Hazard

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

Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
0 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2026

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