Class I Recall for Medtronic’s HeartWare HVAD Pump Parts

Patrice Wendling

May 28, 2020

Medtronic is recalling its HeartWare ventricular assist device (HVAD) Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft may tear and the strain relief screw may break during assembly prior to implant.

Use of the affected parts may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid build-up around the heart, additional medical procedures, and death, the US Food and Drug Administration (FDA) said in a statement today.

The agency has identified this as a class 1 recall, the most serious type, because of the potential for serious injuries or death.

Medtronic has received 92 complaints related to the pre-implant pump assembly process. In an April 3 safety alert sent to healthcare providers, the device company broke down the events as follows:

  • 54 complaints (0.25%), including 2 deaths related to outflow graft tears and 2 deaths related to subsequent complications following outflow graft intervention

  • 38 complaints (0.17%) were related to broken strain relief screws. No patient harm has been reported because of broken strain relief screws. Product damage was identified prior to or during implant in 74 cases and post-implant in 18 cases.

The HVAD system 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.

The recall affects 4924 devices distributed between March 1, 2018 and April 1, 2020. The affected models are HVAD pump outflow graft 1125, HVAD pump implant kit 1103, and HVAD implant accessories kit 1153.

The safety alert provides instructions regarding assembly and attachment of the components and advises physicians to continue to practice standard perioperative and immediate postoperative patient management to detect the issue.

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