HeartWare Battery — Class I medical device recall Z-1266-2022
Ongoing recall by Medtronic Inc, reported 2022-06-29, distributed nationwide. Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, result
| Recall number | Z-1266-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Minneapolis, MN, United States |
| Recall initiated | 2022-05-05 |
| Classified | 2022-06-21 |
| Reported by FDA | 2022-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, ES, FI, FR, GB, HU, IT, NL, NO, NZ, PL |
| Quantity | 429 batteries |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00888707008778 |
| Serial numbers | BAT934844, BAT934846, BAT934848, BAT934849, BAT934850, BAT934851, BAT934852, BAT934853, BAT934854, BAT934855, BAT934857, BAT934858, BAT934859, BAT934861, BAT934862, BAT934863, BAT934865, BAT934866, BAT934867, BAT934868, BAT934869, BAT934870, BAT934871, BAT934873, BAT934874 and 404 more |
| Model numbers | 1650DE |
| Expiration dates | 2022-04-30 |
Product
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1266-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.