# FDA recall Z-2059-2020

> **Heartware, Inc.** · Class I · device recall initiated 2020-04-03.

## Product

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

## Reason for recall

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-2059-2020
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-04-03
- **Report date:** 2020-06-03

- **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-2059-2020

## Citation

> AI Analytics. FDA recall Z-2059-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2059-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*