April 14, 2014 — Covidien has recalled two medical devices used to treat brain aneurysms because the devices can cause stroke or death. The Teflon (polytetrafluoroethylene or PTFE) coating on certain products can delaminate (fall off) and cut off circulation through arteries. No injuries or deaths have been linked to the problem.
The U.S. Food and Drug Administration (FDA) issued a recall for the following endovascular treatment devices:
- Pipeline Embolization Devices (32 products): This device is used to increase blood-flow in patients with large aneurysms in the brain.
- Alligator Retrieval Devices (621 products): This device is used to retrieve other devices doctors use to treat aneurysms.
The products were manufactured from May 2013 to March 2014 and sold in the U.S., Canada, Australia, Europe, and Latin America.
The company discovered the problem during internal testing. Covidien alerted customers to the recall by letter on April 1, 2014. They are arranging for replacement of the recalled products.
Teflon (also known as PTFE) is a coating used on nonstick pans and medical devices to reduce friction between devices and easy navigation through blood vessels. If the coating detaches, it could obstruct blood vessels in the brain and cause a deadly stroke. Last year, Medtronic recalled wires used in certain heart devices because the Teflon coating could detach.
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