Instructions for Use and Patient Manual for HeartWare HVAD System — Class II medical device recall Z-1438-2021
Ongoing recall by Heartware, Inc., reported 2021-04-28, distributed nationwide. IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corr
| Recall number | Z-1438-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-04-20 |
| Reported by FDA | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB, IT, JP |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00888707000017, 00888707000048, 00888707000055, 00888707000307, 00888707000376, 00888707000420, 00888707000437, 00888707000475, 00888707000505, 00888707000697, 00888707000826, 00888707000833, 00888707000857, 00888707000864, 00888707000871, 00888707000888, 00888707000895, 00888707000901, 00888707000918, 00888707001373, 00888707001410, 00888707001427, 00888707001588, 00888707001663, 00888707001694 and 14 more |
| Model numbers | 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE and 19 more |
Product
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.
Reason for recall
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
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-1438-2021. 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.