Zilver PTX Drug Eluting Peripheral Stents are being recalled by Cook Medical because of an issue with the catheters that could potentially compromise patient safety. The products’ delivery system could become dislodged from the inner catheter’s tip, a condition which could cause a host of health complications. This possible adversity includes cardiac arrest, thrombosis, vascular occlusion. Surgery might be required to take the broken tip out of the patient, and in some cases, amputation might be necessary. 13 instances of separation have been reported at this point, one of which led to a fatality and two of which caused some adversity. The products were provided to medical facilities across the country between December 13 and April 16. The devices should be quarantined and sent back to the company.
Follow this link for more about the recall.