HeartWare Ventricular Assist Device — Class II medical device recall Z-1105-2022
Ongoing recall by Heartware, Inc., reported 2022-05-25. Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use
| Recall number | Z-1105-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-05-17 |
| Reported by FDA | 2022-05-25 |
| Countries outside the US | FI, TR |
| Quantity | 59 units |
| UPC / GTIN / UDI-DI | 00888707000420, 00888707007658 |
| Serial numbers | CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268 and 34 more |
| Model numbers | 1420-CONTROLLER, 2.0 |
Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Reason for recall
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
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-1105-2022. 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.