Vanta with AdaptiveStim Implantable Neurostimulator — Class II medical device recall Z-2036-2023
Ongoing recall by Medtronic Neuromodulation, reported 2023-07-05. A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and
| Recall number | Z-2036-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2023-06-06 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Quantity | 3,791 devices |
| UPC / GTIN / UDI-DI | 00763000411923, 00763000478087, 00763000518615 |
| Lot numbers | NMS500135H, NMS500671H, NMS500951H, NMS500964H, NMS500984H, NMS500986H, NMS500988H, NMS500989H, NMS500992H, NMS500994H, NMS501060H, NMS501062H, NMS501064H, NMS501092H, NMS501094H, NMS501097H, NMS501098H, NMS501099H, NMS501100H, NMS501102H, NMS501104H, NMS501105H, NMS501108H, NMS501110H, NMS501117H, NMS501118H, NMS501120H, NMS501121H, NMS501122H, NMS501123H, NMS501125H, NMS501126H, NMS501127H, NMS501129H, NMS501133H, NMS501134H, NMS501135H, NMS501136H, NMS501138H, NMS501141H and 460 more |
| Serial numbers | NMS501860H, NMS501861H, NMS501862H, NMS501863H, NMS501864H, NMS501865H, NMS501866H, NMS501923H, NMS501925H, NMS501926H, NMS501931H, NMS502075H, NMS502076H, NMS502079H, NMS502080H, NMS502083H, NMS502212H, NMS502215H, NMS502220H, NMS502300H, NMS502357H, NMS502362H, NMS502366H, NMS502369H, NMS502399H and 171 more |
| Model numbers | 977006 |
Product
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Reason for recall
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
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-2036-2023. 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.