Boston Scientific Corporation recalls CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Recall date

September 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0140-2026

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);