FDA designates recalls of two vascular catheters as Class I
The FDA has classified Cook Medical’s recall of two catheters used in vascular procedures as Class I, the most serious type.
According to a press release from the agency, there have been 57 complaints about the catheters (Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers, Cook Medical) and 14 reports of serious injuries. There have been no reported deaths.
The catheters have a coated shaft, a valve, a dilator and markers that show up on an x-ray and are used help insert other medical devices used for therapy or diagnosis into the vessels, with the exception of those of the heart and brain, the agency stated in the release.
According to the release, the recall is due to an increased chance for separation at the proximal bond site which may lead to life-threatening adverse events including longer procedure time; another procedure to take out a separated piece; blocking blood flow to vital organs; vessel injury; and bleeding.