UPDATED 04/21/2014. FDA classified this recall as Class I.
AUDIENCE: Risk Manager, Radiology, Surgery
ISSUE: Covidien notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device. The polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature.
Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death.
A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014. This 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.
BACKGROUND: The Pipeline Embolization 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 Retrieval Device is intended for use in the peripheral and neuro‐vasculature for foreign body retrieval.
RECOMMENDATION: Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178