# FDA recall Z-1903-2018

> **Heartware** · Class I · device recall initiated 2018-05-02.

## Product

Heartware Medtronic  HVAD System for cardiac use.  Including the following parts:  (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420  (b) DC Adapter, Product numbers: 1435, 1440  (c) AC Adapter, Product numbers:  1425, 1430  (d) Battery Pack, Product number:  1650DE      Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.

## Reason for recall

Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.

## Distribution

Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, and Vietnam.

## Key facts

- **Recall number:** Z-1903-2018
- **Recalling firm:** Heartware
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-02
- **Report date:** 2018-06-06

- **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-1903-2018

## Citation

> AI Analytics. FDA recall Z-1903-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1903-2018. Source: US FDA. Licensed CC0.

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