FDA Device recall Z-1427-2020
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory…
- FDA Device
- Class I
- ongoing
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class I recall of HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory… by Heartware, citing potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1427-2020 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2020-01-23 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Heartware |
| Distribution | n/a |
Product
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Identifiers
| code_info | Model Number: 1610, all Serial Numbers. Known Model Numbers (Serial Numbers) GTIN Numbers: 1610GB (BCH000001) 0088…Model Number: 1610, all Serial Numbers. Known Model Numbers (Serial Numbers) GTIN Numbers: 1610GB (BCH000001) 00888707002219, 1610GB (BCH000002) 00888707002219, 1610DE (BCH000003) 00888707002202, 1610DE (BCH000004) 00888707002202, 1610IT (BCH000005) 00888707002240, 1610IT (BCH000006) 00888707002240, 1610DE (BCH000007) 00888707002202, 1610DE (BCH000008) 00888707002202, 1610CH (BCH000010) 00888707002196, 1610DE (BCH000011) 00888707002202, 1610DE (BCH000012) 00888707002202, 1610CH (BCH000013) 00888707002196, 1610IT (BCH000014) 00888707002240, 1610DE (BCH000015) 00888707002202, 1610DE (BCH000017) 00888707002202, 1610DE (BCH000018) 00888707002202, 1610DE (BCH000019) 00888707002202, 1610IT (BCH000020) 00888707002240, 1610DE (BCH000021) 00888707002202, 1610GB (BCH000022) 00888707002219, 1610GB (BCH000023) 00888707002219, 1610DE (BCH000024) 00888707002202, 1610IT (BCH000025) 00888707002240, 1610IT (BCH000026) 00888707002240, 1610IT (BCH00002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1427-2020%22
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