# FDA recall Z-1266-2022

> **Medtronic Inc** · Class I · device recall initiated 2022-05-05.

## Product

HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.

## Reason for recall

Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.

## Distribution

Worldwide Distribution.  US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.

## Key facts

- **Recall number:** Z-1266-2022
- **Recalling firm:** Medtronic Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-05
- **Report date:** 2022-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1266-2022

## Citation

> AI Analytics. FDA recall Z-1266-2022. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1266-2022. Source: US FDA. Licensed CC0.

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