Cook Medical of Bloomington, IN has announced the recall of nearly 100,000 of the company’s angiographic catheters for problems related to catheter tip splitting or separation.
According to a press release posted in August to the website of the U.S. Food and Drug Administration (FDA), the company has received 26 separate complaints of catheter-tip splitting and/or separation. In addition 14 separate Medical Device Reports have been filed with the FDA in connection with the defect.
The defects prompting this recall can result in loss of device function. Further, tip separation may impede the flow of blood to body organs, and may require medical intervention to remove a separate segment.
The recalled angiographic catheters were distributed between June 2013 and June 2013 in the U.S. and other countries around the world. See the complete list of catheter part numbers and lot numbers included in this recall.