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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:
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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