BEUDAMED
    FDA Enforcement Class I Ongoing

    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 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1903-2018
    Event ID
    80056
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    May 2, 2018
    Classification Date
    May 31, 2018
    Address
    14400 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    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.

    Code Info

    ALL SERIAL NUMBERS UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement 1403: 00888707000116, 00888707000475 1407: '00888707000291, '00888707000727, '00888707000710, 00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472 1420: '00888707000420, '00888707000437, '00888707002660 (b) 1435: '00888707000109 1440: '00888707000260, '00888707001885, '00888707001496, '00888707002745 (c) 1425: '00888707000093 1430: '00888707000307, '00888707000826, '00888707000833, '00888707000840, '00888707000857, '00888707000871, '00888707000864, '00888707000888, '00888707000901, '00888707000505, '00888707000895, '00888707000918, '00888707001489, '00888707001779, '00888707001786, '00888707001793, '00888707001809, '00888707001816, '00888707001823, '00888707001830, '00888707001847, '00888707001854, '00888707001861, '00888707001878, '00888707002738, '00888707002769, '00888707002776, '00888707002783, '00888707002790, '00888707002806, '00888707004817 (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653, '00888707000376

    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