HeartWare Ventricular Assist Device (HVAD) System… recallZ-1107-2022 · Heartware, Inc. · initiated Mar 30, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Heartware, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
Starting 30-Mar-2022, Medtronic initiated an Urgent Medical Device Notice to VAD Coordinators at customer sites by regional mail and visit in order to inform them of the errors and the corrections impacting the incorrect translation in Finland and Turkey for the HVAD" System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual.
Recall details
- Recall number
- Z-1107-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 30, 2022
- Recalling firm
- Heartware, Inc.
- Quantity
- 645 units
- Product code
- DSQ
- FDA submissions
- P100047
- Distribution
- Finland and Turkey
Product description
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)
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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: R022265 HVAD System Instructions For Use - FI, Lot Number: R025606 HVAD System Instructions For Use (FI), Lot Number: R028504 HVAD System OUS Patient Manual (FI-Finnish), Lot Number: R028100 HVAD System Emergency Responder Guide (TR-Turkish), Lot Number: R025877 HVAD System Patient Manual (TR-Turkish), Lot Number: R021248 HVAD System Patient Manual (TR-Turkish), Lot Number: R021248 HVAD System Patient Manual (TR-Turkish), Lot Number: R027179 HVAD System Patient Manual (TR-Turkish), Lot Number: R027179 HVAD System OUS Instructions For Use (TR-Turkish), Lot Number: R025760R01
Other devices under the same FDA submission
33 devices cleared under P100047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HeartWare® Controller 1403USHeartware Inc. · Ventricular (Assisst) Bypass3 recalls10 deaths1,495 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assisst) Bypass1 recall1,126 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass2 recalls606 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall615 reports
- HVAD® Pump Implant Kit MCS1705PUHeartware Inc. · Ventricular (Assist) Bypass7 recalls36 deaths203 reports
- HVAD® Controller 1403USHeartware Inc. · Ventricular (Assist) Bypass548 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall487 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assist) Bypass1 recall281 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall159 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90079).
- Z-1102-2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
- Z-1103-2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- Z-1104-2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- Z-1105-2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
- Z-1106-2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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