The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2191-2021·Announced 2021-08-18

HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure

Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist 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: This recall is classified FDA Class I, the most serious regulatory category. The source text explicitly states 'mortality' associated with the device, indicating deaths have occurred. Combined with reports of neurological adverse events and critical device malfunction risks, this meets the Critical threshold.

Plain-English summary

The HeartWare HVAD Pump Implant Kit (REF 1153) is a left ventricular assist device intended to help failing hearts pump blood. Medtronic is recalling all 163 units distributed worldwide, including throughout the United States.

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

Patients with implanted HVAD systems should contact their healthcare provider immediately to discuss their individual situation and options. Healthcare providers should verify whether they have patients with implanted units and consult Medtronic for guidance on patient management.

The recalled product

Product
HeartWare HVAD Pump Implant Kit, REF 1153
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac / Left Ventricular Assist Device
Hazard
Affected units
163

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: 00888707000147 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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