Food, drugs, devices › Heartware, Inc.
Device recall: HeartWare HVAD Pump Implant Kit, REF 1103
Heartware, Inc. (Miami Lakes, FL) initiated this device recall on 3 Jun 2021; FDA lists 10 product records under event 88197, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Heartware, Inc. has 32 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Heartware, Inc., Miami Lakes, FL.
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."
Distribution
"Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2188-2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | 647 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2189-2021 | HeartWare HVAD Pump Implant Kit, REF 1104 | 943 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2190-2021 | HeartWare HVAD Pump Implant Kit, REF 1125 | 4078 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2191-2021 | HeartWare HVAD Pump Implant Kit, REF 1153 | 163 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2192-2021 | HeartWare HVAD Driveline Extension Cable, REF 100 | 338 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2193-2021 | HeartWare HVAD Driveline Extension Cable, REF 100US | 443 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2194-2021 | HeartWare HVAD Implant Kit, REF 1104JP | 63 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2195-2021 | HeartWare HVAD Implant Kit, REF MCS1705PU | 439 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2196-2021 | HeartWare HVAD Outflow Graft, REF MCS1725OG | 459 units | Class I | Ongoing | 18 Aug 2021 |
| Z-2197-2021 | HeartWare HVAD Pump Accessories, REF MCS1753AK | 76 units | Class I | Ongoing | 18 Aug 2021 |
Context
Other enforcement events for Heartware, Inc.
All 32 events for Heartware, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.