August 11, 2015 — Cook Medical initiated a voluntary recall July 2 of 2,239 lots of beacon tip angiographic catheters. A total of 95,167 devices globally are subject to this recall. The products include specific versions and lot numbers of the Torcon NB Advantage beacon tip catheters, Royal Flush Plus beacon tip high-flow catheters and Slip-Cath beacon tip catheters.
Beacon tip angiographic catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram used to diagnose heart conditions. Cook Medical has received complaints that the catheter tip may split or separate from the catheter. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.
The catheters in this recall were distributed between June 2013 and June 2015. Product can be identified by the part number and lot number provided on the outer package product label.
The lot numbers for products subject to the recall can be found at the following link: http://mms.businesswire.com/...
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.
Adverse events or quality problems experienced with use of the product may also be reported to the U.S. Food and Drug Administration (FDA).
For more information: www.fda.gov/medwatch