Cook Medical Issues Recall for Beacon Tip Catheters
The US Food and Drug Administration (FDA) is alerting physicians about a voluntary recall issued by Cook Medical last month affecting over four million catheters with the company’s Beacon Tip Technology. The company is asking that use of the products be discontinued immediately and returned to Cook as soon as possible.
The recall, issued April 15, 2016, and posted to the FDA’s MedWatch website today, comes after 30 medical device reports concerning tip fracture and/or separation. Affected devices include angiography and angioplasty catheters used in the peripheral and coronary vascular system, including the carotids. The full list of products is specified in a Cook Medical press release posted on the FDA website.
According to a Cook, a range of adverse events may occur as a result of tip fracture or separation, including “loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment.” The complications could include “device fragments in the vascular system, genitourinary system, or other soft tissues,” while fragments within the vascular system “could result in embolization to the heart or lungs, or occluding blood flow to end organs.”
The cause of tip fracture/separation appears to be polymer degradation, the Cook release notes, adding that storage temperature, room humidity, and use of certain whole room decontamination products may be contributing to the problem, although other factors are being investigated.
The agency is asking physicians to report adverse events or quality problems related to the use of the device through the FDA's MedWatch Adverse Event Reporting program.
Food and Drug Administration. Cook Medical issues global, voluntary recall of catheters with Beacon Tip technology. http://www.fda.gov/Safety/Recalls/ucm499055.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published on: May 3, 2016. Accessed on: May 4, 2016.