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Heartware: Medical Device Recalls in 2018

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Heartware in 2018. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2017
2018
  • 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.
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