Class I — Medtronic Inc
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| Product | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System. |
| Quantity | 429 batteries |
| 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. |
| Initiated | 2022-05-05 |
| Classified | 2022-06-21 |
| Recall number | Z-1266-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Medtronic Inc (Z-1266-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90228/
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