The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2195-2021·Announced 2021-08-18

HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates

Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.

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 combined with explicit reports of higher mortality rates associated with the device when compared to other left ventricular assist devices, meeting the Critical severity threshold per the rubric.

Plain-English summary

The HeartWare HVAD Implant Kit is a left ventricular assist device (LVAD) implanted in patients with severe heart failure to help pump blood throughout the body. Approximately 439 units of this device (REF MCS1705PU) have been distributed worldwide.

Mediatronic is recalling the HVAD System following observational clinical comparisons that demonstrated a higher frequency of neurological adverse events and mortality in patients using this device compared to other commercially available left ventricular assist devices. Additionally, complaints have been received indicating the internal pump may delay or fail to restart.

Patients who have received this implant should contact their physician or healthcare provider without delay. Healthcare providers should review clinical data regarding the device and discuss management options with affected patients. Do not attempt to self-manage any device-related concerns.

The recalled product

Product
HeartWare HVAD Implant Kit, REF MCS1705PU
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Implant
Hazard
Affected units
439

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 (5)

  • GTIN: 00888707005715
  • 00888707007160
  • 00888707007139
  • 00888707005364
  • 00888707009041 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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