Lower riskMedical device recall · FDA · Published May 5, 2022
Medtronic HeartWare Battery Model 1650DE: Battery weld defect may cause malfunction
Medtronic recalls HeartWare Battery Model 1650DE (serial numbers listed) due to weld defect causing battery malfunction. No power or improper charging may occur.
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
“Medtronic HeartWare Battery Model 1650DE: Battery weld defect may cause malfunction.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60726-medtronic-heartware-battery-model-1650de-battery-weld-defect-may-cause. Based on FDA recall #Z-1266-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1266-2022%22&limit=1).
The FDA announced on May 5, 2022, that Medtronic Inc. is recalling HeartWare Batteries, Model #1650DE, due to a weld defect causing malfunction. The agency stated the batteries may fail to provide power or hold a charge.
How to tell if you have it
Brand: Medtronic
Product: HeartWare Battery, Model #1650DE
UPC: 00888707008778
Serial numbers: BAT935012 through BAT934966 (see record for full list)
Expiration date: 30-APR-22
Quantity: 429 batteries
Distribution: Worldwide, including US, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom
The hazard
According to the FDA, batteries for the HVAD system have a weld defect affecting internal components. This results in the battery malfunctioning and no longer providing power or preventing the battery from holding a complete charge or properly recharging.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since September 10, 2017. Recent Medtronic recalls include the Sphere-9 Catheter Recall dated March 11, 2026, and the Abre Venous Stent Recall dated December 4, 2025. Other recent recalls of similar products include HeartMate 11V Backup Battery Recall (May 13, 2026), Thoratec HeartMate 3 LVAS Kits Recall (May 13, 2026), and HeartMate 3 System Controller Recall (May 13, 2026).
How to tell if you have this one
Check if your HeartWare Ventricular Assist Device (HVAD) system includes the HeartWare Battery Model #1650DE with the serial numbers listed in the recall notice. The batteries have an expiration date of April 30, 2022.
Brand
Medtronic
Product
Medtronic Inc recalls HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Battery Serial Number
Look for the serial number on the battery to confirm if it's in the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.” 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 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1266-2022 (May 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1266-2022 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.