Medical Device Safety and Recalls: Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) Expands Recall for Ventricular Assist Device Controllers and DC Adapter

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) Expands Recall for Ventricular Assist Device Controllers and DC Adapter

Medtronic Mechanical Circulatory Support is expanding this recall to include an additional product code and instructions to exchange recalled products.

The company recalled the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death.

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