Irish firm Covidien has recalled certain lots of its two cerebral aneurysm medical devices, citing risk of stroke or death in patients caused by potential delamination of the polytetrafluoroethylene (PTFE) coating applied to the delivery wire.
The company has voluntarily recalled some of its Pipeline embolisation device and Alligator retrieval devices that were manufactured and distributed between May 2013 and March 2014.
Covidien noted that the PTFE coating applied to the delivery wire of the devices can delaminate and detach, potentially leading to embolic occlusion in the cerebral vasculature.
According to the company, the PTFE coating is designed to minimise friction between devices and ease navigation through the vasculature.
Covidien discovered this issue through internal product testing, although it has so far not received any reports of patient injuries related it.
The Pipeline embolisation device for treating adults with large or giant, wide-necked brain aneurysms of the major artery supplying the front of the brain called the internal carotid artery from the petrous to the superior hypophyseal segments.
The Alligator retrieval device is for use in the peripheral and neuro-vasculature for foreign body retrieval.
Particularly affected by this recall are 32 Pipeline embolisation devices and 621 Alligator retrieval devices.
This issue involves Pipeline embolisation devices sold in the US, Australia, France, Germany and UK, and the Alligator retrieval devices, which is sold in the US, Australia, Canada, Europe and Latin America.
On 1 April, Covidien alerted customers by letter and is now arranging for replacement of the recalled products. The company has also notified the US Food and Drug Administration (FDA) and other regulators regarding the issue.
Image: The Pipeline embolisation device. Photo: courtesy of BusinessWire/Covidien plc.