BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-1903-2018 · Initiated May 2, 2018

    Recall

    Recall Number
    Z-1903-2018
    Event Number
    80056
    Firm
    Heartware
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 2, 2018
    Posted
    May 21, 2018
    Address
    14400 NW 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    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.

    Action

    The firm notified physicians and healthcare professionals about the device correction by letter on 05/02/2018. The letter explained problem and provided recommendations for effective power source management of the system. Medtronic began notifying VAD Clinicians in the US on May 31, 2018, mainly via 2-day courier, and OUS via locally approved methods, of a newly available field service. A field service for application of a lubricant to the HVAD System power source connectors to mitigate the potential for transient interruptions of the electrical connection between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller is now available.

    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.

    Quantity

    175878 devices