Z-1107-2022Class II

HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder...

Name: Z-1107-2022 HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder...
Creator: Heartware, Inc.
Published: 2022-03-30
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2022-03-30 / Open, Classified / root cause: labeling and UDI

FDA source

Heartware, Inc. began a recall of HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder... on 2022-03-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1107-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-30
Posted: 2022-05-17
Recalling firm: HeartWare, Inc.
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)
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 645 units
Distribution: Finland and Turkey
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1102-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17
Z-1103-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17
Z-1104-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17
Z-1105-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17
Z-1106-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17
Z-1107-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)