Affected devices include the company’s Centimeter, Aurous Centimeter and Beacon Tip Centimeter sizing catheters. (The FDA website contains a full list of affected lots.)
Sizing catheters offer use in angiographic procedures by physicians trained and experienced in angiographic techniques. Sizing catheters have marker bands that properly orient the device within the anatomy. The catheters come in a variety of lengths (70 cm and 100 cm) and tip configurations (straight, PIG and VCF).
Cook Medical identified that marker bands on impacted products may be at increased risk of cracking/breakage. Potential adverse events could 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, 2026, Cook reports no serious injuries and no deaths associated with the issue.
On April 2, Cook sent all affected customers a letter instructing users to not use the affected catheters and return them to the company. It told customers to examine inventory and quarantine affected products that remain unused before returning them. Customers should immediately cease further distribution and use of the catheters and report adverse events to Cook Medical.
Last year, the company recalled its Beacon Tip angiographic catheters for a separate issue.
