Cook Medical Recalls Sizing Catheters Due to Marker Band Cracking Risk
Summary
FDA issued an early alert notifying healthcare providers that Cook Medical's Centimeter, Aurous Centimeter, and Beacon Tip Centimeter Sizing Catheters may have marker bands at increased risk of cracking or breakage. Potential adverse events include increased procedural time, device fragmentation, vessel injury, and life-threatening harm or death in worst-case scenarios. Healthcare providers should immediately stop using affected devices and return them to Cook Medical.
What changed
Cook Medical issued an urgent recall notification on April 2 for Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters, and Beacon Tip Centimeter Sizing Catheters after identifying that marker bands on impacted products may be at increased risk of cracking or breakage. Potential adverse events include increased procedural time, device fragmentation, vessel injury, and life-threatening harm or death in worst-case scenarios. As of April 2, no serious injuries or deaths had been reported.\n\nHealthcare providers, hospitals, and distributors must immediately cease use and distribution of affected products, quarantine remaining inventory, and return products to Cook Medical. Clinical staff should report any adverse events to Cook Customer Relations or through FDA's MedWatch program. The FDA is currently reviewing this potentially high-risk device issue and will provide updates as new information becomes available.
What to do next
- Stop using affected Cook Medical sizing catheters immediately
- Quarantine and return all affected products to Cook Medical
- Report adverse events to Cook Customer Relations or FDA MedWatch
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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 recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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
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