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Medical Daily

Health

Elena Vega

FDA Issues an Early Alert on Boston Scientific Carotid Catheters After Reports of Tips Breaking Off

FDA Boston Scientific United States

A device designed to prevent stroke during carotid artery procedures is being pulled from hospital shelves because its tip can break off inside an artery, where it may cause the exact injury the device exists to prevent.

The FDA issued an early alert on July 24 about two Boston Scientific products: the ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. Boston Scientific sent affected customers a letter on July 9 recommending they immediately stop using specific lots and return them.

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