Dublin, Ireland-based Covidien has issued a voluntary recall of certain lots of its Pipeline Embolization Device and Alligator Retrieval Device due to the potential for the polytetrafluoroethylene coating on the delivery wire to delaminate and detach from the devices.
The Pipeline Emoblization Devices and Alligator Retrieval Devices are used in endovascular and neurovascular treatment, respectively. If the PTFE coating were to delaminate, the patient could experience embolic occlusion in the cerebral vasculature and be at a higher risk of stroke and/or death, according to a company news release.
The issue was discovered during internal testing, and the company has not received any reports of patient injuries to date, according to the news release.
Covidien has identified 32 Pipeline Emoblization Devices and 621 Alligator Retrieval Devices affected by the recall.
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