FDA Device recall Z-0582-2019
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (H…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (H… by Heartware, citing HVAD Battery Charger units manufactured with wrong inductors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0582-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-19 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Heartware |
| Distribution | US |
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
HVAD Battery Charger units manufactured with wrong inductors.
Identifiers
| code_info | BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH00043…BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH000435, BCH000440, BCH000442, BCH000446, BCH000451, BCH000456, BCH000459, BCH000464, BCH000465, BCH000470, BCH000471, BCH000472, BCH000475, BCH000484, BCH000485, BCH000486, BCH000490, BCH000493, BCH000495, BCH000500, BCH000502, BCH000503, BCH000507, BCH000514, BCH000523, BCH000524, BCH000525, BCH000526, BCH000527, BCH000528, BCH000530, BCH000531, BCH000534, BCH000537, BCH000543, BCH000553, BCH000554, BCH000556, BCH000564, BCH000565, BCH000567, BCH000570, BCH000573, BCH000574, BCH000575, BCH000576, BCH000577, BCH000579, BCH000580, BCH000583, BCH000586, BCH000590, BCH000592, BCH000593, BCH000594, BCH000595, BCH000598, BCH000601, BCH000602, BCH000603, BCH000607, BCH000610, BCH000612, BCH000616, BCH000628, BCH000631, BCH000633, BCH000635, BCH000637, BCH000640, BCH000644, BCH000645, BCH000653, BCH000654, BCH000656, BCH000657, BCH000658, BCH000659, BCH000660, BCH000666, BCH0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2019%22
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