Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
type: Dataset
description: FDA recall Z-2036-2023 — Medtronic Neuromodulation is recalling Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
  type: MedicalDevice
  manufacturer: Medtronic Neuromodulation
claims: FDA recall Z-2036-2023: Medtronic Neuromodulation is recalling Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
claims: FDA classified recall Z-2036-2023 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2036-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2036-2023
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Medtronic Neuromodulation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-06-06
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS503748H, NMS504643H, NMS504701H, NMS504404H, NMS504802H, NMS504344H, NMS504771H, NMS504778H, NMS504650H, NMS501450H, NMS504544H, NMS501538H, NMS503203H, NMS503064H, NMS501373H, NMS503404H, NMS504791H, NMS504792H, NMS501978H, NMS502528H, NMS501313H, NMS501469H, NMS503521H, NMS502644H, NMS504254H, NMS502974H, NMS504955H, NMS503078H, NMS503079H, NMS504657H, NMS501285H, NMS501484H, NMS504381H, NMS501266H, NMS502517H, NMS502681H, NMS504772H, NMS501163H, NMS504243H, NMS502056H, NMS504636H, NMS505065H, NMS503237H, NMS501226H, NMS502346H, NMS502407H, NMS503392H, NMS503395H, NMS504259H, NMS504337H, NMS504402H, NMS504606H, NMS504610H, NMS505010H, NMS505012H, NMS505013H, NMS505014H, NMS505015H, NMS503450H, NMS504406H, NMS505034H, NMS504527H, NMS501897H, NMS504444H, NMS504523H, NMS504981H, NMS503627H, NMS502402H, NMS503862H, NMS501278H, NMS501953H, NMS502022H, NMS504561H, NMS504740H, NMS504825H, NMS505032H, NMS503326H, NMS501135H, NMS502277H, NMS502454H, NMS501656H, NMS503278H, NMS504220H, NMS504847H, NMS502102H, NMS503307H, NMS504371H, NMS504859H, NMS501491H, NMS501512H, NMS501557H, NMS502447H, NMS502504H, NMS502682H, NMS502759H, NMS502933H, NMS502959H, NMS502983H, NMS502984H, NMS503141H, NMS503336H, NMS503340H, NMS503525H, NMS503527H, NMS503530H, NMS503726H, NMS503727H, NMS504032H, NMS504033H, NMS504124H, NMS504130H, NMS504433H, NMS504438H, NMS504453H, NMS504489H, NMS504532H, NMS504652H, NMS504682H, NMS504687H, NMS504773H, NMS504782H, NMS504812H, NMS504875H, NMS501148H, NMS503632H, NMS504477H, NMS502266H, NMS501527H, NMS503001H, NMS503018H, NMS503102H, NMS504555H, NMS504724H, NMS505059H, NMS502144H, NMS503613H, NMS503551H, NMS504311H, NMS502767H, NMS503143H, NMS501282H, NMS501371H, NMS501468H, NMS501620H, NMS501684H, NMS501993H, NMS501998H, NMS501999H, NMS502000H, NMS503177H, NMS503205H, NMS502743H, NMS504597H, NMS501382H, NMS501384H, NMS501543H, NMS502180H, NMS…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

FDA recall Z-2036-2023: Medtronic Neuromodulation is recalling Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
type: Claim
text: The FDA logged enforcement record Z-2036-2023: Medtronic Neuromodulation is voluntarily recalling Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-06. Affected lots/codes: GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS503748H, NMS504643H, NMS504701H, NMS504404H, NMS504802H, NMS504344H, NMS504771H, NMS504778H, NMS504650H, NMS501450H, NMS504544H, NMS501538H, NMS503203H, NMS503064H, NMS501373H, NMS503404H, NMS504791H, NMS504792H, NMS501978H, NMS502528H, NMS501313H, NMS501469H, NMS503521H, NMS502644H, NMS504254H, NMS502974H, NMS504955H, NMS503078H, NMS503079H, NMS504657H, NMS501285H, NMS501484H, NMS504381H, NMS501266H, NMS502517H, NMS502681H, NMS504772H, NMS501163H, NMS504243H, NMS502056H, NMS504636H, NMS505065H, NMS503237H, NMS501226H, NMS502346H, NMS502407H, NMS503392H, NMS503395H, NMS504259H, NMS504337H, NMS504402H, NMS504606H, NMS504610H, NMS505010H, NMS505012H, NMS505013H, NMS505014H, NMS505015H, NMS503450H, NMS504406H, NMS505034H, NMS504527H, NMS501897H, NMS504444H, NMS504523H, NMS504981H, NMS503627H, NMS502402H, NMS503862H, NMS501278H, NMS501953H, NMS502022H, NMS504561H, NMS504740H, NMS504825H, NMS505032H, NMS503326H, NMS501135H, NMS502277H, NMS502454H, NMS501656H, NMS503278H, NMS504220H, NMS504847H, NMS502102H, NMS503307H, NMS504371H, NMS504859H, NMS501491H, NMS501512H, NMS501557H, NMS502447H, NMS502504H, NMS502682H, NMS502759H, NMS502933H, NMS502959H, NMS502983H, NMS502984H, NMS503141H, NMS503336H, NMS503340H, NMS503525H, NMS503527H, NMS503530H, NMS503726H, N…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-2036-2023 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.