Medtronic to recall certain lots of Pipeline, Alligator, X-Celator devices
Medtronic announced that it has notified customers of a voluntary recall of certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group. This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. At the initiation of this recall, 84,278 units potentially affected by this recall had been distributed worldwide. The products were manufactured from July 2014 to September 2016.