FDA Device recall Z-1266-2022
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System
- FDA Device
- Class I
- ongoing
- Published 2022-06-29
On 2022-06-29 the FDA classified a Class I recall of HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System by Medtronic, citing 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 prev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1266-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-05-05 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | US |
Product
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
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.
Identifiers
| code_info | GTIN 00888707008778. Serial numbers BAT935012, BAT935059, BAT935008, BAT935009, BAT935018, BAT935020, BAT935022, BAT93…GTIN 00888707008778. Serial numbers BAT935012, BAT935059, BAT935008, BAT935009, BAT935018, BAT935020, BAT935022, BAT935023, BAT935047, BAT934999, BAT935003, BAT935010, BAT935329, BAT934928, BAT934934, BAT935160, BAT935078, BAT934997, BAT935027, BAT935048, BAT934953, BAT934933, BAT934948, BAT934853, BAT934854, BAT934858, BAT934895, BAT934899, BAT934901, BAT934903, BAT934904, BAT934905, BAT934927, BAT934932, BAT934935, BAT934940, BAT934979, BAT934981, BAT935109, BAT935112, BAT935116, BAT935117, BAT935120, BAT935122, BAT935124, BAT935127, BAT935132, BAT935133, BAT935134, BAT935136, BAT934846, BAT934848, BAT934849, BAT934850, BAT935137, BAT935142, BAT935143, BAT935145, BAT935146, BAT935148, BAT935150, BAT935151, BAT935152, BAT935154, BAT935155, BAT935156, BAT935157, BAT935158, BAT935161, BAT935162, BAT935163, BAT935164, BAT935260, BAT935301, BAT935302, BAT935303, BAT935201, BAT935202, BAT935203, BAT935172, BAT935173, BAT935174, BAT935175, BAT935176, BAT935177, BAT935178, BAT935179, BAT935 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1266-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.