Sizing Catheter Issue from Cook Medical

Affected Product

The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain sizing catheters be removed from where they are used or sold. The affected devices are:

• Centimeter Sizing Catheters
• Aurous Centimeter Sizing Catheters
• Beacon Tip Centimeter Sizing Catheters

The full list of affected product lots can be found here.  

What to Do

Do not use affected sizing catheters. Return affected products to Cook Medical.  

On April 2, Cook sent all affected customers a letter recommending the following actions:

• Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products.
• Return the affected product(s) to Cook Medical.
• Share this notice with appropriate personnel within your organization or with any organization where the affected devices have been transferred.
• Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: mailto:CustomerRelationsNA@CookMedical.com.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. 

Reason for Alert

Cook identified that the marker bands on impacted products may be at an increased risk of cracking/breakage.  

Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death. As of April 2, Cook has reported no serious injuries and no deaths associated with this issue.  

Device Use

Sizing catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Sizing catheters have marker bands that can be used to properly orient the device within the anatomy. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Cook at 812-339-0235.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

• Content current as of:

  04/09/2026

Source