Covidien Issues Recalls For Two Medical Devices

By Ryan Brinks

Covidien recently issued voluntary recalls for certain lots of its Pipeline embolization device and its Alligator retrieval device, due to a polytetrafluoroethylene (PTFE) coating delamination and detachment issue on their delivery wires. The company is not yet aware of any patient injuries or deaths as a result of the life-threatening flaw.

The recall stems from a change in the manufacturing process at one of Covidien's suppliers, according to a Wall Street Journal article. It affected 32 devices of the Pipeline product and 621 devices of the Alligator line, which were sold over the past year in North America, Latin America, Europe, and Australia. As a result, production of the affected devices has been halted until the FDA clears their manufacturing processes.

The flaw was discovered through internal product testing. If left uncorrected, PTFE delamination and detachment could lead to embolic occlusion in the cerebral vasculature.

According to Covidien’s press release, the Pipeline device “is used for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.” The Alligator device is used for foreign body retrieval in the peripheral and neuro-vasculature.

Unaffected inventories are sufficient to replace the recalled products, but “continued availability will depend on the length of the regulatory review process,” Covidien spokesman Peter Lucht told the WSJ.

Covidien's recall pales in comparison to a similar Teflon coating-related recall issued by Medtronic last year, when almost 15,000 delivery wires put heart device patients at risk due to possible delamination, the WSJ article noted.

Covidien was also responsible for a recent, unrelated Class 1 medical device recall in December 2013, when a software issue had the potential to cause the Puritan Bennett 840 ventilator system to fail.

The Puritan ventilator system was used to provide continuous ventilation to critically ill patients — many of whom could not breathe without the ventilator. In that recall, more than 56,000 devices had been sold across the globe.