CLASS I ONGOING Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
HVAD Implant Kit recalled by Heartware
Heartware is recalling HVAD Implant Kit, distributed nationwide in the US. The recall was initiated on 3 Jun 2021 and the FDA has classified it as Class I.
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-2194-2021
- FDA event ID
- 88197
- Recalling firm
- Heartware, Miami Lakes, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 3 Jun 2021
- FDA classified
- 6 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2021 | Recall initiated by company | |
| 6 Aug 2021 | Classified by FDA | +64 days |
| 18 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
HeartWare HVAD Implant Kit, REF 1104JP
Where it was distributed
Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
Questions about this recall
Why was it recalled?
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Which lots are affected?
GTIN: 00888707005838 All serial numbers
Where was it sold?
Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
9 other products · FDA event 88197This product is part of a recall event; the main page for the event is HVAD Pump Implant Kit recalled by Heartware.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | HVAD Pump Implant Kit recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Pump Implant Kit recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Outflow Graft recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Pump Accessories recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Driveline Extension Cable recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Pump Implant Kit recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Pump Implant Kit recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Driveline Extension Cable recalled by Heartware | Heartware | Device Malfunction | Nationwide | |
| CLASS I | HVAD Implant Kit recalled by Heartware | Heartware | Device Malfunction | Nationwide |
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