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# Medtronic Class 1 Recall of HVAD Heart Pump
- URL: https://www.fdaweb.com/medtronic-class-1-recall-of-hvad-heart-pump/
- Published: 2020-05-28T12:00:00.000Z
- Updated: 2026-09-14T16:16:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146880

Medtronic has recalled (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of the pump may tear and the strain relief screw may break during assembly prior to implant but might not be noticed until, during or after the pre-implant pump assembly and attachment to the HVAD pump. Using affected products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-heartware-hvad-pump-outflow-graft-and-outflow-graft-strain-relief-due-risk-breaks?utm%5Fcampaign=2020-05-28%20Recall%20HeartWare%20HVAD%20Pump&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. Medtronic says it has received 92 complaints related to the pre-implant pump assembly process, which includes both the strain relief screw breaking and outflow graft tears.

The HVAD is intended to help the heart deliver blood to the rest of the body. It is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy in patients where new transplants are not planned.