FDA designates Class 1 recall for angiographic catheter

Editor's Note

The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death.

The recall was reportedly motivated by reports of tip separation both prior to and during patient contact. Risks associate with device fragmentation or separation include sepsis, vessel perforation, thrombosis, embolism, cardiac arrythmia, and death. At the time of FDA’s June 25 announcement, the supplier has reported three injuries and no deaths.

In Cook’s May 15 letter, the supplier recommended all users quarantine affected products and share its notice with all appropriate personnel, down to the user level. The full FDA announcement offers additional detail, including contact information and a full list of affected devices.