Official recall record
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-06
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00763000411923
- Brand on record
- Medtronic Neuromodulation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-04-08 · US FDA — Medical Devices
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the follow - 2025-11-20 · US FDA — Medical Devices
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A - 2025-04-03 · US FDA — Medical Devices
Enhanced Verify Evaluation Handset (CFN HH90130FA)
All 6 official recall notices naming Medtronic Neuromodulation on this site →
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