The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2190-2021·Announced 2021-08-18

HeartWare HVAD heart pump implants recalled for neurological events and mortality

Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification establishes a critical-level recall. The source documents a growing body of clinical comparisons showing higher frequency of neurological adverse events and mortality associated with the HVAD system compared to alternative devices, indicating deaths have been reported in relation to this device.

Plain-English summary

Medtronic is recalling the HeartWare HVAD Pump Implant Kit (REF 1125), a left ventricular assist device intended to support heart function in patients with advanced heart failure. The recall affects 4,078 units distributed worldwide, including throughout the United States, Europe, and the Middle East.

The recall follows a growing body of observational clinical comparisons showing that HVAD users experienced a higher frequency of neurological adverse events and mortality compared to patients using other commercially available left ventricular assist devices. Additionally, Medtronic received complaints that the internal pump may delay or fail to restart, creating additional risk.

Patients who have received a HeartWare HVAD implant should contact their healthcare provider or Medtronic immediately to discuss their individual risk and available options. Physicians and facilities that have used or implanted this device should review the recall notice and communicate with affected patients.

The recalled product

Product
HeartWare HVAD Pump Implant Kit, REF 1125
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac assist device
Hazard
Affected units
4,078

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 (3)

  • GTIN: 00888707000222
  • 00888707007641
  • 00888707005685 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 →

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