April 14, 2014 — Covidien has recalled the Pipeline Embolization and Alligator Retrieval devices because the Teflon coating can detach and cause a deadly stroke.
The voluntary recall was announced by the U.S. Food and Drug Administration (FDA) and includes the following devices:
- Pipeline Embolization Device
- Alligator Retrieval Devices
The recall includes about 650 devices. The Pipeline Embolization deice is used to increase blood-flow in people who have large brain aneurysms. The Alligator Retrieval device is used to remove other devices doctors are using to treat brain aneurysms.
The coating on the devices is Teflon or polytetrafluoroethylene (PTFE). If it delaminates, particles can potentially block off an artery in the brain and cause a stroke. Last year, Medtronic recalled 15,000 wires used in heart devices because the Teflon coating could delaminate and injure a patient.
The devices were sold in the United States, Canada, Australia, Europe, and Latin America. They were manufactured from May 2013 – March 2014. The problem was discovered through routine internal testing. Covidien has already alerted customers with a letter dated April 1, 2014. The company is arranging for the products to be returned and replaced.
Do I have a Defective Medical Device Lawsuit?
The Schmidt Firm, PLLC is currently accepting defective medical device induced injury cases in all 50 states. If you or somebody you know has been injured by the Covidien Pipeline Embolization or Alligator Retrieval device, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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