Covidien Pipeline™ Embolization Device and Alligator™ Retrieval Device Recalled for Increased risk of Embolic Occlusion in the Cerebral Vasculature, with the Risk of Stroke and/or Death
On April 11, 2014, the FDA announced that Covidien has recalled certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device. The recalled lots were manufactured and distributed from May 2013 to March 2014. FDA Recall 4/11/14
The Pipeline™ Embolization Device is a braided, wire mesh cylindrical implanted device. It is placed within an artery in the brain to treat aneurysms. The Alligator™ Retrieval Device is intended for use in the peripheral and neuro‐vasculature, or blood vessels, for foreign body retrieval.
These devices have a polytetrafluoroethylene (“PTFE”) coating, which is used to ease friction and navigation through the vasculature. The FDA warns that recalled lots pose an increased risk for the delamination and subsequent detachment of this PTFE coating. Delamination could lead to embolic occlusion, or a blockage, in the cerebral vasculature, causing the risk of stroke or death.
If you or a loved one suffered injuries that you believe were caused by the Pipeline™ Embolization Device or Alligator™ Retrieval Device, contact one of the experienced dangerous drug and 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.