FDA Medical Device Recalls (openFDA)
Heartware, Inc.: 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)
- Recall number
- Z-1107-2022
- 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)
- Status
- Open, Classified
- Initiated
- 2022-03-30
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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
- 645 units
- Distribution
- Finland and Turkey
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P100047"]
- Product code
- DSQ
- Firm FEI
- 3007042319
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28