CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report
Ventricular Assist Device (Hvad) System recalled by Heartware
Heartware is recalling Ventricular Assist Device (Hvad) System, individual pamphlets: Hvad¿ System Emergency. The recall was initiated on 30 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1107-2022
- FDA event ID
- 90079
- Recalling firm
- Heartware, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Mar 2022
- FDA classified
- 17 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2022 | Recall initiated by company | |
| 17 May 2022 | Classified by FDA | +48 days |
| 25 May 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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)
Where it was distributed
Finland and Turkey
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Finland and Turkey
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 90079This product is part of a recall event; the main page for the event is Ventricular Assist Device (HVAD) System Controller recalled by Heartware.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ventricular Assist Device (HVAD) System Controller recalled by Heartware | Heartware | Other | FL | |
| CLASS II | Ventricular Assist Device (HVAD) System recalled by Heartware | Heartware | Other | FL | |
| CLASS II | Ventricular Assist Device (HVAD) System Controller recalled by Heartware | Heartware | Other | FL | |
| CLASS II | Ventricular Assist Device (HVAD) System Controller recalled by Heartware | Heartware | Other | FL | |
| CLASS II | Ventricular Assist Device (HVAD) System, Pump Implant Kit recalled | Heartware | Other | FL |
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