FDA announces recall of 2 different steerable guiding sheaths
The FDA has announced that Oscor, a Florida-based healthcare technology company focused on cardiac care solutions, is recalling 14 lots of its Destino Twist 14F and Guidestar 14F steerable guiding sheaths.
The interventional devices, typically used for vascular procedures, have been found to have issues with the hub cap and seal on the proximal end of the handle detaching during use. The Destino Twist 14F and Guidestar 14F sheathes affected by this recall were distributed to customers and hospitals from June to November 2021.
“Oscor Inc. is notifying its distributors and customers by email and is arranging for the return of all recalled products,” according to the FDA advisory.
Click here for more information, including the exact model and lot numbers included in the recall.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.