Cook Medical Catheter Recall Is Really Serious

The Class I-level recall involves tens of thousands of catheter tips that may split or separate.

Chris Newmarker

Updated August 6, 2015

FDA has issues a Class I designation for a Cook Medical catheter recall involving 95,167 devices around the world.

Cook (Bloomington, IN) said Monday that it initiated the voluntary recall on July 2, and that it involves 2,239 lots of Beacon tip angiographic catheters. The recall showed up FDA's database on Wednesday as Class I-level.

The Beacon catheters were distributed between June 2013 and June 2015. Specific lot numbers are available with the Cook news release.

The problem with Beacon catheters involves tip splitting or separation, which has resulted in adverse events, according to Cook Medical The company has received 26 complaints of catheter-tip splitting and/or separation. Cook says there have been 14 Medical Device Reports to date in which a tip split or separation occurred.

Tip splitting could lead to loss of device function, according to Cook. Tip separation may require medical intervention to retrieve a separated segment. A tip separation might also occlude blood flow to end organs.

Cook Medical says customers and distributors have been notified with recall notification letters requesting that they stop using the devices and return them. FDA and other regulatory agencies around the world have also been notified.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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