Medical Device Safety and Recalls: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Medtronic is recalling certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters. They are issuing this recall due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. If the PTFE separates from the device, it could enter the blood stream of the patient. PTFE particles in the blood stream may lead to downstream blood clots and/or irreversible brain injuries including ischemic stroke, thrombosis, and hemorrhage.

The use of affected product may cause serious adverse health consequences, including death.

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