# FDA recall Z-0067-2019

> **Heartware, Inc.** · Class II · device recall initiated 2018-08-28.

## Product

Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers:  1403, 1407, and 1420    Product Usage:  The HeartWare  HVAD  System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

## Reason for recall

Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0067-2019
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-10-10
- **Termination date:** 2019-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0067-2019

## Citation

> AI Analytics. FDA recall Z-0067-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0067-2019. Source: US FDA. Licensed CC0.

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