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Cook Medical has notified customers to remove specific sizing catheters from use and distribution.

The affected products include the Centimeter, Aurous Centimeter, and Beacon Tip Centimeter sizing catheters. A complete list of impacted lot numbers is available on the FDA website.

These devices are used in angiographic procedures by physicians trained in such techniques. They feature marker bands to help ensure accurate positioning within the anatomy and are available in different lengths (70 cm and 100 cm) and tip styles (straight, PIG, and VCF).

The company identified that the marker bands on certain units may be prone to cracking or breaking. This defect could lead to longer procedure times, complications from device fragmentation or separation, and potential vessel injury. In the most severe cases, fragmentation could result in life-threatening harm or death.

As of April 2, 2026, no serious injuries or deaths have been reported in connection with this issue.

On that date, Cook Medical issued a letter to all affected customers instructing them to stop using the devices and return them. Customers were also advised to review their inventory, quarantine any unused affected products, and discontinue further distribution. Any adverse events should be reported to the company.

This follows a separate recall last year involving the company’s Beacon Tip angiographic catheters.

© Cook Medical Inc.