Class 1 Recall - Beacon Tip Angiographic Catheters
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Beacon Catheters made by Cook medical received a CLASS 1 FDA recall recently due catheter tips slipping or separating. The recalled products include: Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters.
If the catheter tip does slip or separate it can enter a patient's bloodstream causing serious injury. If treatment is not provided to retrieve the tip it may lead to a patient's death. Additionally, the malfunctioning catheter tips may cause the catheter to malfunction.
Twenty six reports of the catheter malfunction have been reported to Cook, 14 of which resulted adverse events. Beacon Catheters are used to inject contrast dye into blood vessels in the heart in preparation for X-rays.