Devices

Alert on Cook Medical Sizing Catheters

FDA has issued an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical, warning healthcare providers to stop using the devices and return affected products. Sizing catheters are commonly used in angiographic procedures to help clinicians measure and navigate blood vessels.

The agency says it is aware that Cook Medical notified customers on 4/2, advising the removal of specific catheter products from use and distribution. The affected devices include Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters, and Beacon Tip Centimeter Sizing Catheters.

According to the alert, the issue stems from marker bands on the catheters that may be at increased risk of cracking or breaking during use. These marker bands are critical for helping physicians position the device accurately during angiographic procedures.

FDA says such failures could lead to complications including prolonged procedures, device fragmentation or separation, and potential injury to blood vessels. In worst-case scenarios, the agency warned, device breakage could result in life-threatening harm or death.

As of 4/2, Cook Medical has reported no serious injuries or deaths associated with the issue.

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