Cook Medical Recalls Catheters Linked to Serious Injuries

Cook Medical has recalled nearly 27,000 Beacon Tip Catheters after reports of tip separation, which the FDA says may lead to severe complications such as sepsis, vessel perforation, embolism, or death. The FDA classified the action as a Class I recall, indicating the highest risk level.

The recall, initiated in May, followed four field complaints and identified a manufacturing issue tied to a single operator. Affected units were found to have tips that could detach before or during use, potentially causing serious injury.

Customers have been instructed to quarantine unused products and cease distribution immediately. Cook previously recalled similar devices in 2015 and 2016 for the same issue.

The company stated that only catheters manufactured by the identified operator are affected and under recall scope.

01-07-2025