Covidien Recalls Embolization, Retrieval Devices

Susan Jeffrey

April 11, 2014

The US Food and Drug Administration (FDA) today announced Covidien has voluntarily recalled certain lots of its Pipeline Embolization Device and Alligator Retrieval Device.

The issue is the potential for the polytetrafluoroethylene (PTFE) coating on the delivery wire, used to reduce friction and ease navigation through the vasculature, to delaminate and detach.

"Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death," the FDA MedWatch safety alert notes.

The Pipeline device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

The Alligator device is intended for use in the peripheral vasculature and neurovasculature for foreign-body retrieval.

"Covidien learned of this issue through internal product testing," a statement from Covidien said. "The company has not received any reports of patient injuries to date related to this issue."

A total of 32 Pipeline devices and 621 Alligator devices are affected by this recall, all manufactured and distributed from May 2013 to March 2014. The Pipeline device is sold in the United States, Australia, France, Germany, and the United Kingdom, and the Alligator device in the United States, Australia, Canada, Europe, and Latin America.

Covidien alerted customers to the recall by letter on April 1 and is arranging for replacement of the recalled products, the FDA notes.

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