The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2197-2021·Announced 2021-08-18

Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures

Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.

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 recalls score at least 4. The mention of mortality associated with the device from observational clinical data, combined with serious neurological adverse events and pump failure risks in a critical life-sustaining device, meets the rubric criterion for Critical (5).

Plain-English summary

Heartware, Inc. is recalling HeartWare HVAD Pump Accessories (Reference MCS1753AK) worldwide. The recall involves 76 units distributed to the United States and over 30 countries.

The recall is due to observational clinical data showing higher rates of neurological adverse events and mortality with the HVAD system compared to other left ventricular assist devices. Heartware has also received reports that the internal pump may delay or fail to restart, which could affect device function.

The HVAD is a critical device used to support heart function in patients with advanced heart failure. Patients with this device should contact their healthcare provider or Heartware immediately for guidance.

The recalled product

Product
HeartWare HVAD Pump Accessories, REF MCS1753AK
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist Device
Hazard
Affected units
76

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 (2)

  • GTIN: 00888707005371
  • 00888707007597 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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