Covidien Recalls Certain Lots Of Its Pipeline Embolization & Alligator Devices

(RTTNews) - Covidien plc (COV) 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 where the polytetrafluoroethylene 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 and/or death. The company learned of the issue through internal product testing.

A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by the recall. The issue involves both the Pipeline Embolization Device sold in the U.S., Australia, France, Germany and United Kingdom, and the Alligator Retrieval Device, which is sold in the U.S., Australia, Canada, Europe and Latin America.

The Pipeline Embolization Device is indicated for the endovascular treatment of adults 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 and neuro-vasculature for foreign body retrieval.