Covidien is recalling some endovascular devices due to a coating defect.
Covidien initiated a voluntary recall of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices after finding that the polytetrafluoroethylene coating on the delivery wire could delaminate and detach from the devices. Delamination potentially could lead to embolic occlusion in the cerebral vasculature, putting a patient at risk of stroke or death.
The embolization device is used to treat adults with large or giant wide‐necked intracranial aneurysms in the internal carotid artery. The retrieval device is used in the peripheral and neuro‐vasculature to retrieve a foreign body.
The affected devices were manufactured and distributed from May 2013 to March 2014. Dublin-based Covidien sells the embolization devices in the U.S., Australia, France, Germany and the U.K. and the retrieval devices in the U.S., Australia, Canada, Europe and Latin America.
Covidien said it notified clients and is offering replacement products. Physicians and patients should report adverse events or side effects related to the affected devices to the FDA's MedWatch.