Recall Z-1903-2018— Heartware

Class I FDA medical device recall by Heartware, initiated 2018-05-02. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Heartware

Classification

Class I

Status

Ongoing

Initiated

2018-05-02

Firm location

Miami Lakes, FL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.