Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CX Preconnect with TENACIO Pump with InhibiZone Recalled by Boston Scientific Corporation Due to The potential for devices to experience inflation and/or...

Date: September 11, 2025
Company: Boston Scientific Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.

Affected Products

CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);

Quantity: 2288 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report