Heartware HVAD System Batteries (Product 1650DE) - Battery Performance Issues
Heartware recalls HVAD System Batteries (Product Number 1650DE) due to battery performance issues that may cause failure to power the controller or accept charge. Affected units have specific serial numbers and GTIN.
Lower-risk recall
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Contact the company
What happened, in plain English
Heartware is recalling HVAD System Batteries with Product Number 1650DE because they may not power the device's controller or accept charge properly. This could lead to the battery appearing charged while actually discharging. Affected units have specific serial numbers and GTIN. Read more at govinfonow.com/recall/60415-heartware-hvad-system-batteries-product-1650de-battery-performance-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/60415-heartware-hvad-system-batteries-product-1650de-battery-performance-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1512-2022
Cite this page
“Heartware HVAD System Batteries (Product 1650DE) - Battery Performance Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60415-heartware-hvad-system-batteries-product-1650de-battery-performance-issues. Based on FDA recall #Z-1512-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2022%22&limit=1).
Why it’s dangerous
The batteries may fail to power the device's controller or accept charge from the charger. This could cause the battery to appear charged while actually discharging, potentially leading to system failure.
Who’s affected
Patients using Heartware HVAD systems with the recalled battery model (Product Number 1650DE) are most at risk. The recall affects specific serial numbers and GTIN.
How to tell if you have this one
Check if your HVAD system battery has Product Number 1650DE. Look for the GTIN 00763000187767 or the listed serial numbers in the recall notice.
- Brand
Heartware- Product
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE- Category
Medical device
What to do — step by step
Check Battery Serial Number
Identify your battery's serial number to see if it's listed in the recall (e.g., BAT941874, BAT941880, etc.).
Contact Heartware
Reach out to Heartware directly for assistance with the recall process.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark,…” 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 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I check if my battery is affected?
Check the serial number on your battery against the list of affected serial numbers provided in the recall notice.
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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-1512-2022 (June 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1512-2022 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.