Medical Device Safety and Recalls: Medtronic Recalls HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device Because it May Cause Electrical Issues or Pump Stops

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

Title: Medical Device Safety and Recalls: Medtronic Recalls HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device Because it May Cause Electrical Issues or Pump Stops

Medtronic is recalling the driveline splice kit due to a design problem that would prevent the repaired cable assembly from withstanding excessive force or pull (e.g. accidental dropping of controllers or snagging driveline cables). The excessive force or pull could cause damage to the cable assembly and interrupt electrical connection. The company issued these kits between April 2010 and March 2015 to repair previous HVAD driveline cable connector assembly issues.

An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.

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