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Heartware International issues recall of its heart medical assistance device


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3/5/2015
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HeartWare International, a manufacturer of the HeartWare Ventricular Assist System Controllers, issued a voluntary recall of its product.  The product was distributed in the U.S. during the clinical trial period, prior to approval by the FDA in 2012.  The products affected by the recall showed higher susceptibility to electrostatic discharge than the newer models.  If a device experiences the electrostatic discharge (ESD), the heart pump could stop and cause serious injury or death to the patient.  Newer models were manufactured with new designs that prevent electrostatic discharge and these are not affected by the recall.  The recall is estimated to affect 120 patients in the U.S.  The controllers being recalled have product codes 1400 and 1401XX.  HeartWare issued a notice in 2013 informing physicians of the potential issues with ESD and what to look for in patients that have one of the affected controllers.  Some of the factors that can reduce the risk of an ESD event are avoiding dry environments, certain fabrics (such as silk and carpeting), electronic devices prone to static electricity and activities involving static such as vacuuming and removing clothes from the dryer.  HeartWare reported one death and one serious injury as the result of an ESD event caused by one of the defective controllers since 2013.  Physicians have been directed to determine on a case-by-case basis whether it is in the patient's best interests to exchange the affected controller for a new one or allow the patient to continue with the old controller.



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