Covidien Recalls Certain Aneurism Detection Devices Due to Risk of Stroke or Death
The Food and Drug Administration (FDA) posted a press release on April 11, 2014 where Covidien announced its voluntarily recall of two of its aneurism detection devices – the Pipeline™ Embolization Device and Alligator™ Retrieval Device. Covidien provided that it learned of the defect through internal product testing and has not received any injury reports to date related to these two devices at issue.
The voluntary recall was issued due to the polytetrafluoroethylene (PTFE) coating applied to the delivery wire of the devices, which could delaminate and detach from the detection devices at issue. The release provides: “PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. 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 have been affected by this recall. The affected products at issue were manufactured and distributed between May 2013 and March 2014. Both products were available for sale in the United States.
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