|Beacon Tip Angiographic Catheter--Courtesy of Cook Medical|
Cook Medical announced that it is recalling 95,167 Beacon Tip Angiographic Catheters because of reports of tip splitting and/or separation. The FDA reposted the company's release on its website, a sign that this recall is more urgent than most of the other ongoing corrective actions of medical devices.
The agency just confirmed the seriousness of the recall by classifying it as three separate Class 1 correctives actions, one for each model affected. That means "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The company sent a letter to customers on July 2, requesting that they quarantine and discontinue use of all potentially affected units and return the affected versions of the device to the company as soon as possible for credit.
The recall involves 2,239 lots distributed between June 2013 and June 2015. The affected lot numbers are displayed on the Cook and FDA websites.
Cook said it has received 26 complaints of the problem, which has also been documented in 14 adverse event reports. Tip splitting can lead to loss of device function, while tip separation may require intervention to retrieve the fragment so that it does not block the flow of blood to organs, according to a company release.
The affected models are the Torcon NB Advantage Beacon Tip Catheter, Royal Flush Plus Beacon Tip High-Flow Catheter and Slip-Cath Beacon Tip Catheter. The devices are used during aortic and peripheral intervention, as well as interventional radiology procedures.
According to their instructions for use, the catheters have been designed "for percutaneous introduction into the vascular system over an appropriately sized wire guide or through an appropriately sized sheath introducer."
In addition to classifying recalls into one of three categories based on severity, the FDA occasionally posts company press releases on its website as a service to consumers and the media. It does not endorse the company or the recalled product.
In June, the FDA classified Cook's recall of 661 units of its Ring Transjugular Intrahepatic Access Set into Class 2, meaning use of or exposure to the violative product "may cause temporary or medically reversible adverse health consequences."
The Torcon NB Advantage is part of that set.
- read the release
Editor's Note: The information about FDA's Class 1 designation was added to the story.