Medtronic Mechanical Circulatory Support Expands Recall For Ventricular Assist Device Controllers, DC Adapter
Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) recently expanded its Nov. 2016 recall for Ventricular Assist Device controllers and DC Adapter to include an additional product code and exchange instructions. The recall was issued due to a loose power connector in the HeartWare Ventricular Assist Device (HVAD) controller which may result in separation of the pump’s rear driveline connector from the front portion. This separation may allow moisture to enter the controller, potentially resulting in corrosion, electrical issues, reduced speaker volume, and connection failures. Medtronic Mechanical Circulatory Support has since developed an updated HVAD controller as well as power management software to assist in power connector concerns. Affected devices include all HeartWare controllers, product codes 1400, 1401, 1403, 1407 and the newly added 1435 for the HVAD DC adapter. Read the full recall announcement and exchange recommendations here.
Keywords: Heart-Assist Devices, United States Food and Drug Administration
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