Certain lots of Covidien's Pipeline Embolization Device and Alligator Retrieval Device have been recalled. The polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices. Covidien learned of this issue through internal product testing.
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.
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.
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.
See the Recall
See also Medical Law Perspectives, October 2013 Report: Brain Aneurysm and Subarachnoid Hemorrhage: Failure to Diagnose, Delayed Diagnosis, Misdiagnosis