The Recall Desk
SevereFDA (Devices)·Z-2189-2021·Announced 2021-08-18

Heart Pump Device Recalled for Increased Mortality and Device Failure

Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity of Severe. The source documents a higher frequency of neurological adverse events and mortality associated with the device compared to alternatives, plus reports of device restart failure.

Plain-English summary

The HeartWare HVAD Pump Implant Kit (REF 1104) is a left ventricular assist device. Medtronic is stopping distribution and sale of the device.

A growing body of observational clinical comparisons shows the HVAD system has a higher frequency of neurological adverse events and mortality when compared to other commercially available left ventricular assist devices. Healthcare providers have also reported that the internal pump may delay or fail to restart.

The device has been distributed worldwide. Those with questions about the recall should contact their healthcare provider.

The recalled product

Product
HeartWare HVAD Pump Implant Kit, REF 1104
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist / Left Ventricular Assist Device
Hazard
Affected units
943

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • GTIN: 00888707003063
  • 00888707003070
  • 00888707006323
  • 00888707003117
  • 00888707006392
  • 00888707006408
  • 00888707006330
  • 00888707003100
  • 00888707003254
  • 00888707009140
  • 00888707007290
  • 00888707006446
  • 00888707008129
  • 00888707002608
  • 00888707008174
  • 00888707003209
  • 00888707006347 All serial numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · Heartware, Inc.

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Same hazard · increased mortality

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