Use caution Medical device recall · FDA · Published June 3, 2021

Heartware HVAD Pump Implant Kit Recall: Neurological Risks and Mortality

Heartware recalls HVAD Pump Implant Kit REF 1125 due to higher neurological adverse events and mortality risks compared to other LVADs, with internal pump failure concerns.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2190-2021Medical device Heartware ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmHeartware, Inc.14400 Nw 60th Ave · Miami Lakes, FL 33014-2807

✎ GovInfoNow plain-language explainer

Heartware is recalling its HVAD Pump Implant Kit (REF 1125) because clinical studies show it has a higher rate of neurological issues and deaths compared to other ventricular assist devices. The internal pump may also fail to restart properly, posing a risk to users. Read more at govinfonow.com/recall/62398-heartware-hvad-pump-implant-kit-recall-neurological-risks-and-mortality.

Source Summary by GovInfoNow · govinfonow.com/recall/62398-heartware-hvad-pump-implant-kit-recall-neurological-risks-and-mortality · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2190-2021

Cite this page

“Heartware HVAD Pump Implant Kit Recall: Neurological Risks and Mortality.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62398-heartware-hvad-pump-implant-kit-recall-neurological-risks-and-mortality. Based on FDA recall #Z-2190-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2190-2021%22&limit=1).

The FDA announced on June 3, 2021, that Heartware, Inc. is recalling the HeartWare HVAD Pump Implant Kit due to risks of neurological adverse events and mortality. The agency cited a higher frequency of these issues compared to other left ventricular assist devices.

How to tell if you have it

HeartWare HVAD Pump Implant Kit, REF 1125
UPC 00888707000222
UPC 00888707005685
UPC 00888707007641

The hazard

Medtronic is stopping distribution and sales of the HVAD System because observational clinical comparisons show a higher frequency of neurological adverse events and mortality associated with the system. Complaints also indicate that the internal pump may delay or fail to restart.

Context

GovInfoNow's records show Heartware, Inc. has had 17 other recalls since August 28, 2018. Recent updates included changes to controller fault alarms on October 31, 2023, and issues with logfiles from Model 1521 monitors on May 16, 2023. Other recent recalls of similar products include Thoratec HeartMate 3 LVAS Kits Recall (May 13, 2026) and Abiomed Heart Pump Kit Recall (June 11, 2026).

How to tell if you have this one

Check for the Heartware HVAD Pump Implant Kit with serial numbers listed: 00888707000222, 00888707007641, or 00888707005685. This kit was sold under the REF 1125 designation.

Brand
Heartware
Product
HeartWare HVAD Pump Implant Kit, REF 1125
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-2188-2021	HeartWare HVAD Pump Implant Kit, REF 1103; GTIN: 00888707003261 All serial numbers	647 units
Z-2189-2021	HeartWare HVAD Pump Implant Kit, REF 1104; GTIN: 00888707003063, 00888707003070, 00888707006323, 00888707003117, 00888707006392, 00888707006408, 00888707006330, 00888707003100, 00888707003254, 00888707009140, 00888707007290, 00888707006446, 00888707008129, 00888707002608, 00888707008174, 00888707003209, 00888707006347 All serial numbers	943 units
Z-2190-2021	HeartWare HVAD Pump Implant Kit, REF 1125; GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers	4078 units
Z-2191-2021	HeartWare HVAD Pump Implant Kit, REF 1153; GTIN: 00888707000147 All serial numbers	163 units
Z-2192-2021	HeartWare HVAD Driveline Extension Cable, REF 100; GTIN: 00888707009294, 00888707000345, 00763000187651 All serial numbers	338 units
Z-2193-2021	HeartWare HVAD Driveline Extension Cable, REF 100US; GTIN: 00888707000024 All serial numbers	443 units
Z-2194-2021	HeartWare HVAD Implant Kit, REF 1104JP; GTIN: 00888707005838 All serial numbers	63 units
Z-2195-2021	HeartWare HVAD Implant Kit, REF MCS1705PU; GTIN: 00888707005715, 00888707007160, 00888707007139, 00888707005364, 00888707009041 All serial numbers	439 units
Z-2196-2021	HeartWare HVAD Outflow Graft, REF MCS1725OG; GTIN: 00888707007627, 00888707007634 All serial numbers	459 units
Z-2197-2021	HeartWare HVAD Pump Accessories, REF MCS1753AK; GTIN: 00888707005371, 00888707007597 All serial numbers	76 units

Based on the official FDA remedy

What to do — step by step

Contact Heartware
Reach out to Heartware directly to confirm if your specific kit is affected and get guidance on next steps.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jun 3, 2021Firm started the recall
Aug 6, 2021FDA classified it Class I
Aug 18, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/62398-heartware-hvad-pump-implant-kit-recall-neurological-risks-and-mortality">Heartware HVAD Pump Implant Kit Recall: Neurological Risks and Mortality (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2190-2021 (June 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2190-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.