# FDA recall Z-1512-2022

> **Heartware, Inc.** · Class I · device recall initiated 2022-06-28.

## Product

HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

## Reason for recall

Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.

## Distribution

Worldwide distribution.  US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.

## Key facts

- **Recall number:** Z-1512-2022
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-28
- **Report date:** 2022-08-24

- **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-1512-2022

## Citation

> AI Analytics. FDA recall Z-1512-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1512-2022. Source: US FDA. Licensed CC0.

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