Cook Medical initiated a recall for a select number of its beacon tip angiographic catheters due to issues with tip splitting or separation, according to a press release published yesterday.
Tip splitting or separation can lead to the loss of device function and separation “may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs,” according to the company.
The Bloomington, Ind.-based company initiated the 2,239 unit lot-specific recall on July 2, for products including the Torcon NB Advantage beacon tip catheters, Royal Flush Plus beacon tip high-flow catheters and Slip-Cath beacon tip catheters, according to the company.
Cook has received 26 complaints and there have been 14 medical device reports to date on the issue, according to the company.
The devices being recalled were distributed between June 2013 and June 2015, the company said. Cook Medical has notified customers and distributors of the issue and requested that the affected units be returned.
The full list of the affected lot numbers is listed in an FDA recall notice posted yesterday.