The U.S. Food and Drug Administration (FDA) said Boston Scientific is recommending a recall of certain percutaneous catheters after receiving reports of the arterial sheath tip detaching or partially detaching
The U.S. Food and Drug Administration (FDA) said Boston Scientific is recommending a recall of certain percutaneous catheters after receiving reports of the arterial sheath tip detaching or partially detaching. Tip detachment may require endovascular intervention or surgical intervention to remove the remaining tip. The affected products are specific batches of ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus. As of July 9, the company reported one serious injury and no deaths as a result of the issue.