Covidien Recalls Pipeline and Alligator Devices

April 11, 2014—Covidien (Mansfield, MA) announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline embolization device and Alligator retrieval device, in which the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke or death. The PTFE coating is used to reduce friction between devices and ease navigation through the vasculature.

The Pipeline embolization device is indicated for the endovascular treatment of adults (age ≥ 22 years) 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 vasculature and neurovasculature for foreign body retrieval.

According to Covidien, the company learned of this issue through internal product testing and it has not received any reports of patient injuries related to this issue. Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products. Additionally, the company notified the US Food and Drug Administration and other regulatory authorities.

Covidien advised that this recall affects a total of 32 Pipeline devices and 621 Alligator devices that were manufactured and distributed from May 2013 to March 2014. The Pipeline devices were sold in the United States, Australia, France, Germany, and the United Kingdom. The Alligator devices were sold in the United States, Australia, Canada, Europe, and Latin America.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by fax at (800) FDA-0178, or by mail. The form can be obtained via download at www.fda.gov/MedWatch/getforms.htm or by calling (800) 332-1088. Covidien Customer Service can be contacted for more information or to report a problem at (800) 716-6700 or by email at customerserviceus@covidien.com.