Cook Medical initiated a global recall of its Beacon Tip catheters, following reports of degrading polymer in the catheter tips, which may lead to fracture or separation.
The recall involves 4,146,309 catheters and covers all catheters within the Beacon Tip family.
There have been 30 reports to date, and an investigation revealed that conditions such as storage temperature, humidity, use of vaporized hydrogen peroxide may have contributed to the degradation.
Adverse events that may arise as a result of the degradation include:
The company is advising customers to discontinue use of all units and to return the affected products to Cook Medical.