FDAnews Device Daily Bulletin

Cook Medical Expands Recall of Beacon Tip Angiographic Catheters

Oct. 15, 2015

Cook Medical has initiated a voluntary recall for select sizes of Beacon tip angiographic catheters, an expansion of the voluntary lot-specific recall issued on July 2, 2015.

The recall covers specific versions of the Torcon NB Advantage BeaconTip catheters, Royal Flush Plus Beacon tip high-flow catheters, Slip-Cath Beacon tip hydrophilic catheters and Shuttle Select Slip-Cath catheters.

There have been 42 medical device reports concerning the Beacon tip angiographic catheters regarding tip splitting or separation, which has the potential to lead to loss of device function.

These catheters covered by the expanded recall were distributed globally between September 2012 and September 2015. — Michael Cipriano