FDA Device recall Z-1107-2022
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System E…
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System E… by Heartware, citing finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ven….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1107-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-30 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Heartware |
| Distribution | n/a |
Product
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish)
Reason
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Identifiers
| code_info | No GTIN HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Gui…No GTIN HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R025893 HVAD System Instructions For Use (FI), Lot Number: R020771 HVAD System Instructions For Use (FI), Lot Number: R020771 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R021391 HVAD System Patient Manual (FI-Finnish), Lot Number: R021391 HVAD System Patient Manual (FI-Finnish), Lot Number: R |
|---|
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-1107-2022%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.