Medtronic HeartWare Ventricular Assist HVAD System Battery Charger… — Class II medical device recall Z-0582-2019
Terminated recall by Heartware, Inc., reported 2018-12-19, distributed nationwide. HVAD Battery Charger units manufactured with wrong inductors.
| Recall number | Z-0582-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2018-11-19 |
| Classified | 2018-12-07 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, IN, IT, LB, LV, NL, PL, SE, SK, TR, ZA |
| Quantity | 2,031 |
| Model numbers | 1600US |
Product
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.
Reason for recall
HVAD Battery Charger units manufactured with wrong inductors.
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-0582-2019. 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.