Medical Device Safety and Recalls: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connectors which may Prevent Alarm from Sounding and Pump Stops

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

Title: Medical Device Safety and Recalls: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connectors which may Prevent Alarm from Sounding and Pump Stops

HeartWare Inc. is recalling 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.

HeartWare issued a related recall for the HVAD on July 29, 2016.

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