Cook Medical has issued a Class I recall of its Beacon Tip 5.0 Fr Angiographic Catheters following reports of tip separation that resulted in three serious injuries. The Food and Drug Administration classified this as the most serious type of recall, warning that continued use of the devices could lead to severe complications including sepsis, embolism, or cardiac arrhythmia.
The recall affects nearly 27,000 blood vessel imaging catheters that were withdrawn from the market after the company learned that the catheter tip may separate from the device during procedures. Cook Medical alerted customers on May 15, 2025, instructing immediate cessation of use and distribution of the affected products.
Safety Concerns and Patient Impact
The FDA's Class I classification reflects the potential for serious harm if the tip separates from the device during a procedure. According to Cook Medical, tip separation could lead to outcomes including sepsis, vessel perforation, and death. While no deaths have been reported in connection with this recall, the company confirmed three serious injuries linked to the issue.
The catheters are typically used in blood vessel imaging procedures, making the tip separation particularly concerning given the critical nature of these interventions. Customers have been instructed to quarantine unused units and notify all relevant personnel or facilities about the recall.
Investigation Findings
Cook Medical's investigation revealed that the fault results from process deviation by one specific operator. The company began the latest recall in May after receiving four field complaints about tip separation occurring before and during patient contact. All applicable parts manufactured by the identified operator are included in the recall scope.
History of Similar Issues
This recall represents the third time Cook Medical has recalled Beacon devices for tip separation issues. The company previously recalled Beacon devices in 2015 and 2016 for similar safety concerns, indicating a recurring problem with this product line.
The repeated recalls raise questions about the manufacturing processes and quality control measures for these critical medical devices. The identification of a specific operator as the source of the current manufacturing deviation suggests systemic issues in the production oversight of these catheters.
