FDA: Medtronic heart device could malfunction
Medtronic this week alerted health care providers to a defect in its Heartware Ventricular Assist Device System that may cause the internal pump to malfunction, the Food and Drug Administration announced yesterday. The company is investigating to determine which devices may be affected. FDA recommends that health care providers and patients make decisions about removing or exchanging the device on a case-by-case basis, considering the patient’s clinical status and surgical risks.
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