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The QMN Weekly Bulletin
Quality / Medical Devices / Commercial Operations
Covidien Recalls Pipeline Embolization Device and Alligator Retrieval Device
April 18, 2014
Covidien is recalling certain lots of its Pipeline embolization devices and Alligator retrieval devices due to a defect in the coating applied to the delivery wire. According to the Irish devicemaker, the polytetrafluoroethylene coating may delaminate and detach from the devices, potentially causing embolic occlusion in the cerebral vasculature and putting the patient at risk of stroke or death.
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