The Recall Desk
CriticalFDA (Devices)·Z-2194-2021·Announced 2021-08-18

HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality

Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal 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: This is an FDA Class I recall of a life-critical implanted device with reported mortality. The source explicitly identifies higher mortality and neurological adverse events associated with the device compared to alternatives, which constitutes known serious harm.

Plain-English summary

The HeartWare HVAD Implant Kit (REF 1104JP), manufactured by Heartware, Inc., is being recalled worldwide. This device is an implanted left ventricular assist device used to help the heart pump blood. The recall affects 63 units distributed across the United States and over 30 countries worldwide.

Medtronic initiated the recall based on observational clinical data showing that the HVAD system is associated with a higher frequency of neurological adverse events and higher mortality rates compared to other commercially available left ventricular assist devices. Additionally, the company received complaints that the internal pump may delay or fail to restart.

Patients and healthcare providers with the recalled device should contact Medtronic for guidance on next steps and available options.

The recalled product

Product
HeartWare HVAD Implant Kit, REF 1104JP
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist Device
Hazard
Affected units
63

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: 00888707005838 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 · mortality

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