The Recall Desk
CriticalFDA (Devices)·Z-2188-2021·Announced 2021-08-18

FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality

Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The source explicitly references 'mortality associated with the system,' indicating known patient deaths, which elevates the severity to Critical (score 5).

Plain-English summary

The HeartWare HVAD Pump Implant Kit (REF 1103) is a ventricular assist device designed to support heart function in patients with advanced heart failure. Medtronic is recalling this device worldwide due to safety concerns.

The manufacturer stopped distribution and sale of the HVAD System after observing a higher frequency of neurological adverse events and mortality in patients receiving the device compared to other commercially available left ventricular assist devices. The device also has complaints associated with the internal pump potentially delaying or failing to restart.

This Class I recall affects 647 units distributed worldwide, including throughout the United States and to numerous countries in Europe, the Middle East, Asia, Africa, and other regions. All serial numbers are included in the recall.

The recalled product

Product
HeartWare HVAD Pump Implant Kit, REF 1103
Manufacturer
Heartware, Inc.
Category
Medical Device — Ventricular Assist Device
Hazard
Affected units
647

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 (1)

  • GTIN: 00888707003261 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 · neurological events

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