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Boston Scientific Implantable Cardioverter Defibrillators:Recall-Practitioners should not use devices unless, until FDA reviews, approves changes made by the manufacturer



Title: Boston Scientific Implantable Cardioverter Defibrillators:Recall-Practitioners should not use devices unless, until FDA reviews, approves changes made by the manufacturer
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Boston Scientific Implantable Cardioverter Defibrillators: Recall

Audience: Cardiology healthcare professionals, patients

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.

Product families included in this advisory include Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.

Read the complete MedWatch 2010 Safety summary, including a link to the FDA Statement at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205409.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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