FDA issues update on heart device recall
All hospitals may request a backup controller with modified software for the Heartware Ventricular Assist Device System to use in certain circumstances if the primary controller fails to restart the pump, the Food and Drug Administration announced today. Medtronic last year recalled over 1,600 of the devices because the internal pump may stop and fail to restart, among other safety concerns, but said the risk of removing an implanted device may outweigh the benefits.
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