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April 11, 2014
08:10 EDTCOVCovidien implements voluntary recall of devices
Covidien announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene, or PTFE, coating applied to the delivery wire could delaminate and detach from the devices. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death. A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014.Covidien learned of this issue through internal product testing. The company has not received any reports of patient injuries to date related to this issue. Covidien alerted customers to the recall by letter on April 1, and is arranging for replacement of the recalled products. The FDA and other regulatory bodies also have been notified, the company said.
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