Cook Medical recalled more than 38,000 of its angiographic catheters in the U.S. after receiving reports that the catheter tip may split or separate from the catheter. Of the 26 reports, 14 resulted in adverse events.
The catheters were distributed from June 6, 2013, through June 25, 2015. The recall affected the following products: the Beacon Tip Torcon NB Advantage catheters, Beacon Tip Royal Flush Plus High-Flow catheters and Slip-Cath Beacon Tip catheters.
Cook Medical recalled 95,167 devices worldwide, including 38,895 in the U.S. The company said tip splitting may lead to loss of device function and may require medical intervention.
The FDA did not indicate the nature of the adverse events, but it mentioned it was classified as a Class I recall. Class I recalls are defined as “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”