FDA Device recall Z-1110-2022
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System by Medtronic, citing errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1110-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-30 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001
Reason
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
Identifiers
| code_info | Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW292…Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW29211, HW29212, HW29219, HW29229, HW29246, HW29248, HW29249, HW29252, HW29265, HW29266, HW29268, HW29271, HW29273, HW29274, HW29276, HW29279, HW29282, HW29283, HW29284, HW29285, HW29286, HW29287, HW29290, HW29293, HW29302, HW29309, HW29310, HW29329, HW29333, HW29387, HW29426, HW29465, HW29472, HW29485, HW29502, HW29503, HW29522, HW29526, HW29532, HW29533, HW29534, HW29535, HW29536, HW29538, HW29539, HW29540, HW29541, HW29542, HW29543, HW29546, HW29547, HW29548, HW29549, HW29551, HW29552, HW29562, HW29567, HW29579, HW29583, HW29586, HW29587, HW29588, HW29589, HW29590, HW29592, HW29593, HW29594, HW29595, HW29600, HW29602, HW29603, HW29604, HW29612, HW29629, HW29635, HW29650, HW29660, HW29661, HW29664, HW29665, HW29666, HW29667, HW29668, HW29669, HW29670, HW29671, HW29672, HW29673, HW29674, HW29675, HW29676, HW29685, HW29686, HW29687, HW29700, HW29701, HW29702, HW29717, HW29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2022%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.