Cook Medical Recalls Beacon Tip 5.0 Fr Angiographic Catheters Due to Safety Concerns

Cook Medical has issued a recall of its Beacon Tip 5.0 Fr Angiographic Catheters after reports of tip separation that may lead to serious injury or death. The FDA has classified this as a Class I recall—the most serious type—warning that continued use of the devices could result in severe complications, including sepsis, embolism, or cardiac arrhythmia.

The company alerted customers on May 15, 2025, advising immediate cessation of use and distribution of the affected products. Customers are instructed to quarantine unused units and notify all relevant personnel or facilities. While no deaths have been reported, Cook confirmed three serious injuries linked to the issue. The catheters are typically used in blood vessel imaging procedures.