Approximately 4.1 million catheters have been recalled by Cook Medical after 30 medical device reports were received by the FDA’s MedWatch reporting program. Reports indicated that the tip of the catheters can fracture or separate during a procedure. The recall is one of the largest by Cook Medical in years, expanding on previous recalls from 2015. They have had many of their devices, such as IVC filters (link to IVC filter article), also recalled in the past.
Cook Medical is currently investigating what is causing the Beacon Tip catheters to fail. According to a preliminary investigation by Cook Medical, the problem may be environmental. Cook’s investigation suggests that Vaporized Hydrogen Peroxide (VHP), used to decontaminate operating rooms, may be causing a polymer in the catheter to break down. Cook Medical also suggested that temperature and room humidity where the catheters are stored may be contributing factors.
The catheters affected by this global recall include all catheters with the Beacon Tip technology. A full list of devices affected is provided below. Courtesy of FDA.gov.
- Beacon® Tip Torcon NB® Advantage Catheter
- Beacon® Tip Royal Flush® Plus High-Flow Catheter
- Beacon® Tip Centimeter Sizing Catheter
- Beacon® Tip White Vessel Sizing Catheter
- Beacon® Tip Vessel Sizing Catheter
- Shuttle® Select Slip-Cath® Beacon® Tip Catheter
- FluoroSet® Radiographic Tubal Assessment Set
- Haskal Transjugular Intrahepatic Portal Access Set
- Kumpe Access Catheter
- Liver Access and Biopsy Needle Set
- Neff D’Agostino Percutaneous Access Set
- Aprima™ Access Nonvascular Introducer Set
- Selective Salpingography Catheter with Beacon® Tip
- Transluminal Biliary Biopsy Forceps Set
- White Lumax® Guiding Coaxial Catheter