Boston Scientific Implantable Cardioverter Defibrillators: Recall
MedSun: Newsletter #47, April 2010

FDA MedWatch Safety Alert

FDA notified healthcare professionals that FDA has been notified by Boston Scientific that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted.

FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted.

Additional Information:

FDA MedWatch Safety Alert. Boston Scientific Implantable Cardioverter Defibrillators: Recall. March 19, 2010.

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