Heartware recalls Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Produ…

Recall date

May 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1903-2018

FDA classification

Class I

Brand / firm

Heartware

Sold / distributed

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, L…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.