Cook Medical has initiated a Class I recall of nearly 27,000 Beacon Tip 5.0 Fr Angiographic Catheters following reports of tip separation during procedures. This defect poses significant patient risks, including vessel perforation, sepsis, and even death.
Background
The recall was prompted by four field complaints received in May 2025, highlighting incidents of tip separation before and during use. An internal investigation identified a process deviation by a specific operator as the root cause. Affected devices manufactured by this operator are now being recalled.
Patient Safety Implications
The FDA has classified this recall as Class I, indicating a reasonable probability of serious adverse health consequences or death. Potential complications from using affected catheters include catheter fragmentation, embolization, thrombosis, cardiac arrhythmia, and death.
Recommended Actions
Healthcare providers are advised to:
-
Immediately quarantine all unused affected devices.
-
Cease distribution of the recalled products.
-
Return affected devices to Cook Medical.
-
Report any adverse events to Cook Medical and the FDA.