Vanta Implantable Neurostimulator (INS), Model 977006
type: Dataset
description: FDA recall Z-0132-2025 — Medtronic Neuromodulation is recalling Vanta Implantable Neurostimulator (INS), Model 977006 (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 Implantable Neurostimulator (INS), Model 977006
  type: MedicalDevice
  manufacturer: Medtronic Neuromodulation
claims: FDA recall Z-0132-2025: Medtronic Neuromodulation is recalling Vanta Implantable Neurostimulator (INS), Model 977006
claims: FDA classified recall Z-0132-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0132-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0132-2025
      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: Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-08-21
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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, NMS500397H, NMS500398H, NMS500399H, NMS500402H, NMS500403H, NMS500405H, NMS500407H, NMS500409H, NMS500410H, NMS500411H, NMS500412H, NMS500413H, NMS500414H, NMS500415H, NMS500416H, NMS500417H, NMS500418H, NMS500419H, NMS500420H, NMS500421H, NMS500422H, NMS500423H, NMS500424H, NMS500425H, NMS500426H, NMS500427H, NMS500428H, NMS500429H, NMS500430H, NMS500431H, NMS500432H, NMS500433H, NMS500434H, NMS500435H, NMS500437H, NMS500438H, NMS500439H, NMS500440H, NMS500441H, NMS500442H, NMS500443H, NMS500444H, NMS500445H, NMS500446H, NMS500447H, NMS500448H, NMS500449H, NMS500450H, NMS500451H, NMS500453H, NMS500454H, NMS500455H, NMS500456H, NMS500457H, NMS500458H, NMS500459H, NMS500460H, NMS500462H, NMS500463H, NMS500464H, NMS500465H, NMS500466H, NMS500467H, NMS500468H, NMS500469H, NMS500470H, NMS500471H, NMS500472H, NMS500473H, NMS500474H, NMS500475H, NMS500476H, NMS500479H, NMS500480H, NMS500481H, NMS500482H, NMS500483H, NMS500485H, NMS500486H, NMS500487H, NMS500489H, NMS500490H, NMS500491H, NMS50…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

FDA recall Z-0132-2025: Medtronic Neuromodulation is recalling Vanta Implantable Neurostimulator (INS), Model 977006
type: Claim
text: The FDA logged enforcement record Z-0132-2025: Medtronic Neuromodulation is voluntarily recalling 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-21. Affected lots/codes: 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, NMS500397H, NMS500398H, NMS500399H, NMS500402H, NMS500403H, NMS500405H, NMS500407H, NMS500409H, NMS500410H, NMS500411H, NMS500412H, NMS500413H, NMS500414H, NMS500415H, NMS500416H, NMS500417H, NMS500418H, NMS500419H, NMS500420H, NMS500421H, NMS500422H, NMS500423H, NMS500424H, NMS500425H, NMS500426H, NMS500427H, NMS500428H, NMS500429H, NMS500430H, NMS500431H, NMS500432H, NMS500433H, NMS500434H, NMS500435H, NMS500437H, NMS500438H, NMS500439H, NMS500440H, NMS500441H, NMS500442H, NMS500443H, NMS500444H, NMS500445H, NMS500446H, NMS500447H, NMS500448H, NMS500449H…
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-0132-2025 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.