A recent FDA recall notice outlined the details of a Class 1 recall of four neurovascular products from Medtronic. They are issuing the recall because there’s a potential for the polytetrafluoroethylene (PTFE) coating to detach from parts of the devices. The function of PTFE coating is to ease navigation through the vasculature by reducing friction between devices. If the coating separates from the device, it could enter the patient’s blood stream and cause blood clots and/or irreversible brain damage including ischemic stroke, thrombosis, and hemorrhage.
The devices included in the recall are:
· The Pipeline™ Embolization Device (PED)
· The Alligator™ Retrieval device
· The X-Celerator™ Hydrophilic Guidewire
· The UltraFlow™ and Marathon™ Flow Directed Micro Catheters
