Cook Medical expands beacon tip cath recall

Cook Medical expanded its Class I recall for beacon tip angiographic catheters to include additional lots, according to an FDA press release.

Bloomington, Ind.-based Cook Medical’s Beacon Tip Angiographic Catheters are used to inject contrast die into blood vessels in the heart to prepare for cardiac angiograms used to diagnose heart conditions.

The recall was initially filed in July over issues with tip splitting or separation of the device which can lead to the loss of function and separation that may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

A Class I label from the FDA indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

Cook said it received 26 complaints and there have been 14 medical device reports to date on the issue, according to the FDA and Cook.

The company added an additional 8 catalog numbers and 63 lot numbers to the recall, according to an FDA press release. The recall affects Cook Medical’s Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters and Shuttle Select Slip-Cath Catheters.

A total 408,011 units are being recalled, manufactured between August 10, 2012 and September 10, 2015 and distributed between September 12, 2012 and September 22, 2015.

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