FDA: Medtronic recalls certain neurovascular products

Editor's Note

The Food and Drug Administration (FDA) on October 18 announced the recall by Medtronic 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.

The recall is being conducted because of potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of the devices.

If PTFE particles enter the patient’s bloodstream, it could lead to a thromboembolic event.

PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.