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# Medtronic HeartWare Splice Kit Recall is Class 1: FDA
- URL: https://www.fdaweb.com/medtronic-heartware-splice-kit-recall-is-class-1-fda/
- Published: 2017-05-04T12:00:00.000Z
- Updated: 2026-09-14T22:21:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138616

FDA says that the Medtronic 3/16 recall of all HeartWare Ventricular Assist System pump driveline spice kits distributed between 1/11/11 and 5/23/14 and used before 4/2015 is a Class 1 recall. An agency [notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm556616.htm?ref=fdaweb.com) says that the device helps deliver blood from the heart to the rest of the body in patients who are at risk of death from end-stage left ventricular heart failure and are waiting for a heart transplant.

The system includes a driveline cable that goes through the skin and connects an implanted pump to an external controller that regulates the pump’s speed and function, FDA says. The driveline splice kit is intended to repair the driveline once an electrical break has been identified. The repairs are limited to the section of the driveline that is outside the patient.

FDA says the company recalled the driveline splice kit due to a design problem that would prevent the cable assembly from withstanding excessive force or pull. It says the excessive force or pull could cause damage to the cable assembly and interrupt electrical connection, which could cause the pump to stop with the potential for serious adverse consequences, including death.

Medtronic says that all patients who underwent driveline splice repair after 4/2015 have been spliced with an improved kit and are not affected by the issue.