FDA announces recall of device used in interventional procedures after 3 injuries
The U.S. Food and Drug Administration on Wednesday announced the recall of a device used in interventional radiology after three reported injuries.
The action applies to Cook Medical’s Beacon Tip Catheters, intended for deployment in angiographic, blood vessel imaging procedures. Cook has become aware that the catheters may experience “tip separation,” which was discovered after complaints from the field.
This is a Class 1 recall, the FDA’s most serious designation, indicating the device may cause “serious injury or death, if you continue to use it.”
“If an affected product is used, potential patient harms such as catheter fragmentation and embolization may occur,” the FDA said in an update shared June 25. “Medical consequences associated with device fragmentation or separation may include sepsis, vessel perforation, thrombosis, embolism, cardiac arrythmia and death,” the agency added, emphasizing there have been no reported fatalities.
Bloomington, Indiana-based Cook Medical messaged impacted customers on May 15 about the safety issue. It encourages interventional specialists who perform these procedures to examine inventory and quarantine impacted products that remain unused. Rads are urged to immediately cease utilization and notify all impacted personnel.
In a separate notice, the FDA said a total of 26,986 units are affected by the recall. Beacon Tip 5.0 Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. They’re available in various configurations including different shaft lengths and tip curves, with some manufactured using hydrophilic coating. You can find further information on how to return products and the number to contact Cook Medical here.
The product first earned U.S. FDA clearance in 2017.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.