FDA Device recall Z-0483-2024
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU by Heartware, citing updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0483-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-31 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Heartware |
| Distribution | n/a |
Product
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Reason
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Identifiers
| code_info | GTIN 00888707005364, Serial Numbers: HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313,…GTIN 00888707005364, Serial Numbers: HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765; GTIN 00888707005715, Serial Numbers: HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial Numbers: HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Heartware
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
FDA Device · Class II · 2023-12-13 · Heartware - 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Device · Class II · 2023-12-13 · Heartware - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Device · Class II · 2023-12-13 · Heartware
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0483-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.