Recall of Multiple Medtronic Neurovascular Products
On December 1, 2016 the U.S. Food and Drug Administration identified a Class I recall of several Medtronic Neurovascular products. Class I recalls are the most serious type of recall, issued only when the FDA finds a reasonable probability that use of the product will cause serious adverse health consequences or death.
The devices included in this recall are certain lots of Medtronic’s Pipeline™ embolization device, Alligator™ retrieval device, X-Celerator™ hydrophilic guidewire, and stylet containing UltraFlow™ flow directed micro catheters and Marathon™ flow directed micro catheters. The recall potentially affects over 84,000 products distributed worldwide. The products were manufactured from July 2014 to September 2016.
According to Medtronic, the Pipeline™ embolization device is indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator™ retrieval device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval. The X-Celerator™ hydrophilic guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures. The UltraFlow™ flow directed micro catheter is designed for the subselective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The Marathon™ Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast.
Medtronic has recalled the devices due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on some of their components. If this separated PTFE coating enters the patient’s blood stream there is an increased risk of a thromboembolic (blood clot) event.
If you or a loved one suffered injuries that you believe were caused by a Medtronic Neurovascular product contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.