Medical Device Safety and Recalls: Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots

Cook Medical has expanded its original July 2015 recall for the Beacon Tip Catheter to include additional product lots. The recall now affects 408,011 total catheters distributed in the US.

Cook Medical started the original recall after it received complaints that the catheter tip may split or separate, and could potentially 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.

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