FDA Device recall Z-0132-2025
Vanta Implantable Neurostimulator (INS), Model 977006
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Vanta Implantable Neurostimulator (INS), Model 977006 by Medtronic Neuromodulation, citing model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0132-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-21 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
Vanta Implantable Neurostimulator (INS), Model 977006
Reason
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Identifiers
| code_info | UDI/DI 00763000411923, Serial Numbers: NMS500122H, NMS500123H, NMS500130H, NMS500135H, NMS500159H, NMS500190H, NMS5001…UDI/DI 00763000411923, Serial Numbers: NMS500122H, NMS500123H, NMS500130H, NMS500135H, NMS500159H, NMS500190H, NMS500191H, NMS500194H, NMS500201H, NMS500309H, NMS500310H, NMS500312H, NMS500313H, NMS500314H, NMS500315H, NMS500316H, NMS500317H, NMS500318H, NMS500319H, NMS500320H, NMS500321H, NMS500322H, NMS500323H, NMS500326H, NMS500327H, NMS500329H, NMS500330H, NMS500332H, NMS500333H, NMS500334H, NMS500335H, NMS500336H, NMS500337H, NMS500339H, NMS500340H, NMS500341H, NMS500343H, NMS500344H, NMS500345H, NMS500347H, NMS500348H, NMS500350H, NMS500351H, NMS500356H, NMS500357H, NMS500358H, NMS500359H, NMS500360H, NMS500361H, NMS500363H, NMS500364H, NMS500365H, NMS500366H, NMS500368H, NMS500369H, NMS500370H, NMS500371H, NMS500372H, NMS500373H, NMS500374H, NMS500375H, NMS500376H, NMS500377H, NMS500378H, NMS500379H, NMS500380H, NMS500382H, NMS500383H, NMS500385H, NMS500386H, NMS500387H, NMS500388H, NMS500389H, NMS500390H, NMS500391H, NMS500392H, NMS500393H, NMS500394H, NMS500395H, NMS500396H, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0132-2025%22
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