FDA Medical Device Recalls (openFDA)
Heartware: 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 number
- Z-1903-2018
- Recalling firm
- Heartware
- 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.
- Status
- Open, Classified
- Initiated
- 2018-05-02
- Posted
- 2018-05-21
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 175878 devices
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- P100047
- Product code
- DSQ
- Firm FEI
- 3007042319
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28