FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. A full list of affected catheters is provided here. Previously, a recall for the Beacon Tip was issued in July 2015, which was subsequently expanded in October 2015.
Cook Medical’s Beacon Tip is a sizing catheter with a radiopaque tip that provides visibility within the vascular system. The FDA’s recall notice states that the affected catheters suffered from polymer degradation of the catheter tip, which resulted in tip fracture or separation, in at least some cases.
The FDA recall explains that, the degradation could result in:
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.
According to Cook Medical, storage temperature, room humidity and the use of certain whole room decontamination products may contribute to the problem.
In a previous report, Cook found that complaints regarding the degrading tips were isolated to hospitals using new sterilization techniques. The sterilization techniques involved vaporized hydrogen peroxide that was used to clean operating rooms of patients infected with resistant bacteria, such as MRSA. According to the hospital, the affected catheters were left out in the operating room during the sterilization process. However, Cook states that there may be other undetermined contributors to the problem and will continue to investigate.