Certain lots of four Medtronic neurovascular products are being recalled because they may present a risk of blood clots. The coating on the devices, which is made of polytetrafluoroethylene, may separate from the delivery wire or stylets. If this happens, the coating material may enter the blood stream and cause a blood clot. Certain lots of Medtronic’s Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire and stylet containing UltraFlow flow director micro catheters and Marathon flow directed micro catheters are affected by the voluntary recall.
According to the Wall Street Journal, 84,278 units manufactured since July 2014 to last month may be affected. The products were distributed globally.
Medtronic says the U.S. Food and Drug Administration (FDA) and other regulatory agencies have been alerted to the recall. The company says it started notifying customers by issuing Oct. 5 recall letters. The letters ask customers to quarantine all affected products return them to Medtronic.
In June, Medtronic recalled thousands of temporary lead pacing systems because they can connect to a hazardous voltage. The recall affects 11,697 of the model 6416; of these, 6,174 were distributed in the United States. The temporary system is designed for intracardiac pacing and/or EGM recording for up to seven days. The recall was issued because these devices do not meet design standards meant to prevent the lead from connecting to a dangerous voltage, the FDA said.
In an emailed statement, Medtronic spokesman Ryan Mathre said “The electrical connectors on the leads do not have the proper insulation required by the standard,” according to Qmed. The recall was designated as Class II by the FDA, meaning it is a situation where exposure to the recalled product may cause temporary or medically reversible health consequences or where the possibility of serious injury or death is remote.