Thousands of Angiographic Catheters Recalled Due to Tip Malfunction

Cook Medical is recalling nearly 40,000 angiographic catheters following 26 reports of malfunction, nearly half of which resulted in adverse events.

The medical device manufacturer received complaints that catheter tips were splitting or separating from its Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters.

If this occurs, the tip could enter the patient’s bloodstream, which could cause serious injury and require additional medical intervention to retrieve the tip, or even lead to death. It could also cause the device to stop working.

The 38,895 affected devices were manufactured from May 9, 2013, to September 1, 2014, and distributed from June 6, 2013, to June 25, 2015. Cook Medical began informing customers of the recall on July 2, 2015.

Among the 26 reported cases of device malfunction, 14 adverse effects have been noted.

Beacon Tip Angiographic Catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram. The catheter is inserted into the body through a small puncture made in the skin and placed into the blood vessel along a guide wire before injecting the contrast dye.

Cook Medical is asking users to immediately quarantine recalled products in their inventory and returned unused items as soon as possible. Customers can also report adverse effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.