Manufacturer Medtronic plc has recalled (officially October 5, 2016) several of its products due to potential separation and detachment of the Polytetrafluoroethylene (PTFE) coating. The PTFE coating is meant to reduce the friction and ease the navigation between the devices but if it separates from the device it could enter the blood stream of the patient. Separated PTFE particles in the bloodstream could lead to downstream blood clots and irreversible brain injuries including ischemic stroke, thrombosis and hemorrhage.
The recalled devices are meant to be used together for the treatment of cerebral aneurysms, a localized, blood-filled ballooning in the wall of a blood vessel. Unfortunately there are thousands of affected lots per product, which makes it all the more important for any patient who has undergone a procedure involving these products contact Napoli Shkolnik PLLC today.
The following is a list of the recalled products and their uses:
- Pipeline™ Embolization Device (PED): a device implanted within an artery in the brain;
- Alligator™ Retrieval Device: micro forceps which are meant to retrieve foreign bodies within the blood vessels of the brain;
- X-Celerator™ Hydrophilic Guidewire: an aid for the catheter placement in the brain during certain surgical procedures; and
- UltraFlow™ and Marathon™ Flow Directed Micro Catheters: designed to handle the infusion of doctor-specified therapeutic agents.
REASON FOR RECALL
This recall has been issued as a result of the possible separation and detachment of the polytetrafluoroethylene (PTFE) coating on portions of the devices. Facilitate navigation and PTFE coating is used to decrease friction between apparatus. It might enter the blood flow of the individual, in the event the PTFE and the apparatus separate. Particles from the blood flow may result in blood clots that are downstream or irreversible brain injuries such as hemorrhage, thrombosis, and stroke.
Medtronic is recalling of 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.
These products are produced, marketed and sold by the Brain Therapies division of Medtronic’s Neurovascular Restorative Therapies Group. The U.S. Food and Drug Administration (FDA) and other regulatory authorities have been notified but at Napoli Shkolnik PLLC we are first and foremost concerned about the welfare of the patients who have been affected along with their family and friends. We encourage you to contact one of our experienced attorneys today to discuss your legal options.