Heartware Medtronic HVAD System for cardiac use — Class I medical device recall Z-1903-2018
Ongoing recall by Heartware, reported 2018-06-06, distributed nationwide. Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter
| Recall number | Z-1903-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Miami Lakes, FL, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GR, HK, HR, HU, IL, IN, IT, JP, KR, KW, LB, LT, LU, LV, MY, NL, NO, NZ, PL, RO, RS, SA, SE, SG, SK, TR, TW, UA, VN, ZA |
| Quantity | 175,878 devices |
| UPC / GTIN / UDI-DI | 00888707000093, 00888707000109, 00888707000116, 00888707000260, 00888707000291, 00888707000307, 00888707000369, 00888707000376, 00888707000420, 00888707000437, 00888707000475, 00888707000482, 00888707000499, 00888707000505, 00888707000710, 00888707000727, 00888707000734, 00888707000741, 00888707000758, 00888707000765, 00888707000772, 00888707000789, 00888707000796, 00888707000802, 00888707000819 and 58 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1903-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.