Ireland-based Covidien has announced a voluntary recall of its Pipeline embolization devices and Alligator retrieval devices as polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.
The PTFE coating, which reduces friction between devices and ease navigation through the vasculature, delamination could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death.
Covidien has recalled the devices after an internal testing revealed a potentially lethal problem with the wires used to deliver them. A total of 32 Pipeline embolization devices and 621 Alligator retrieval devices, which are manufactured and distributed from May 2013 to March 2014, are affected by this recall.
The recall involves both the Pipeline embolization device sold in the US, Australia, France, Germany and the UK, and the Alligator retrieval device that is sold in the US, Australia, Canada, Europe and Latin America. The company is arranging for replacement of the recalled products.
Until now, Covidien has not received any reports of patient injuries to date related to this issue. The company has notified the US Food and Drug Administration (FDA) and other regulatory bodies of this recall.
The Pipeline embolization device has been designed 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 has been designed for use in the peripheral and neuro-vasculature for foreign body retrieval.
Image: Covidien’s Pipeline embolization device. Photo: Courtesy of BusinessWire/Covidien plc