Medtronic is issuing a recall on certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters. The FDA has identified this as a Class I recall, the most serious kind of recall. Use of these devices may cause serious injuries or death.
LIST OF RECALLED PRODUCTS
- Pipeline™ Embolization device
- Alligator™ Retrieval device
- X-Celerator™ hydrophilic guide wires
- UltraFlow™ HPC flow directed micro catheters/Marathon™ flow directed micro catheters
Distribution Dates: November 10, 2014 to August, 5, 2015
Manufacturing Dates: July 2014 to September 2016
REASON FOR RECALL
This recall is being issued 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.
WHAT SHOULD I DO IF I'M AFFECTED?
We encourage anyone who uses one of these devices to contact the experienced Pharmaceutical Litigation team at Napoli Shkolnik, PLLC today.