FDA details Class I catheter recall over safety risk
The U.S. Food and Drug Administration (FDA) has finalized a Class I recall for certain lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters.
These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
Background about this recall
Back in April, the FDA published an early alert because these catheters were associated with an increased risk of cracking or breaking during use. No injuries or deaths had been reported, but the risk was still believed to be significant.
“Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” the agency said at the time. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
The FDA was still reviewing the issue when it shared that early alert. No final decisions had been made about the severity of this recall.
Now, however, that investigation is complete; the FDA has categorized this as a Class I recall, the most severe classification there is.
According to the agency, a Class I recall means there is “a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
What should customers do?
Cook Medical has contacted all affected customers and told them not to use or sell any of these devices. Instead, they should be returned to the company.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.