Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

CrossCath Support Catheter Recalled by Cook Inc. Due to A manufacturing error may cause the radiopaque marker...

Date: November 8, 2019
Company: Cook Inc.
Status: Terminated
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 Cook Inc. directly.

Affected Products

CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.

Quantity: 20

Why Was This Recalled?

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

Where Was This Sold?

This product was distributed to 20 states: AL, CA, CT, FL, GA, IL, MD, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, VA

Affected (20 states)Not affected

About Cook Inc.

Cook Inc. has 262 total recalls tracked by RecallDetector.

Related Recalls

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