Cook Medical has recalled more than four million catheters with Beacon Tip technology that have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture, separation, or both. The problem has resulted in 30 medical device reports to date.
Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
The voluntary recall of 4,146,309 catheters, initiated by Cook on April 15, was disclosed by the FDA on May 4.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to Cook as soon as possible for credit.
This recall includes all lots of catheters with the Beacon Tip technology. Product families involved include: 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; 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; and White Lumax Guiding Coaxial Catheter.
Catheters with Beacon Tip technology are intended for use in a variety of angiographic and other procedures by physicians who are trained and experienced in each of those procedures.
A preliminary investigation has indicated that environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide for whole-room decontamination within health care facilities, may be contributing to the occurrence. Cook Medical recognizes that there may be other undetermined contributors to this issue and will continue to investigate.
Source: FDA; May 3, 2016.