Model Number L211 PROPONENT DR SL MRI Pacemaker
type: Dataset
description: FDA recall Z-0089-2026 — Boston Scientific Corporation is recalling Model Number L211 PROPONENT DR SL MRI Pacemaker (Devices, Class I). 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: Model Number L211 PROPONENT DR SL MRI Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0089-2026: Boston Scientific Corporation is recalling Model Number L211 PROPONENT DR SL MRI Pacemaker
claims: FDA classified recall Z-0089-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0089-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0089-2026
      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 I
      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: Boston Scientific Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-08-20
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. GTIN 00802526559105, Serial Numbers: 100009, 100020, 100022, 100024, 100028, 100030, 100031, 100037, 100038, 100039, 100043, 100046, 100047, 100048, 100049, 100052, 100053, 100058, 100061, 100063, 100066, 100068, 100075, 100077, 100078, 100080, 100083, 100087, 100090, 100091, 100095, 100097, 100098, 100106, 100113, 100122, 100125, 100127, 100130, 100131, 100132, 100133, 100143, 100145, 100156, 100158, 100163, 100166, 100167, 100168, 100170, 100172, 100174, 100175, 100179, 100187, 100188, 100191, 100194, 100198, 100206, 100207, 100209, 100210, 100213, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100230, 100231, 100237, 100244, 100246, 100247, 100248, 100249, 100268, 100269, 100270, 100271, 100275, 100280, 100281, 100290, 100291, 100309, 100316, 100334, 100390, 100395, 100398, 100427, 100430, 100438, 100446, 100460, 100462, 100478, 100482, 100487, 100488, 100493, 100497, 100505, 100509, 100510, 100513, 100514, 100516, 100522, 100527, 100529, 100532, 100537, 100542, 100551, 100555, 100559, 100565, 100567, 100571, 100576, 100578, 100580, 100584, 100585, 100592, 100594, 100598, 100600, 100601, 100606, 100612, 100613, 100617, 100618, 100619, 100621, 100622, 100623, 100631, 100634, 100638, 100643, 100647, 100648, 100649, 100651, 100652, 100653, 100659, 100660, 100668, 100669, 100670, 100672, 100674, 100677, 100680, 100684, 100685, 100700, 100702, 100705, 100708, 100710, 100711, 100717, 100720, 100722, 100723, 100727, 100730, 100731, 100733, 100742, 100746, 100747, 100753, 100755, 100767, 100769, 100772, 100776, 100778, 100782, 100783, 100784, 100789, 100794, 100796, 100799, 100811, 100814, 100815, 100816, 100818, 100820, 100825, 100828, 100829, 100836, 100839, 100840, 100843, 100853, 100854, 100861, 100864, 100866, 100870, 100873, 100874, 100876, 100877, 100879, 100881, 100883, 1008…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0089-2026: Boston Scientific Corporation is recalling Model Number L211 PROPONENT DR SL MRI Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0089-2026: Boston Scientific Corporation is voluntarily recalling Model Number L211 PROPONENT DR SL MRI Pacemaker — reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-20. Affected lots/codes: GTIN 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. GTIN 00802526559105, Serial Numbers: 100009, 100020, 100022, 100024, 100028, 100030, 100031, 100037, 100038, 100039, 100043, 100046, 100047, 100048, 100049, 100052, 100053, 100058, 100061, 100063, 100066, 100068, 100075, 100077, 100078, 100080, 100083, 100087, 100090, 100091, 100095, 100097, 100098, 100106, 100113, 100122, 100125, 100127, 100130, 100131, 100132, 100133, 100143, 100145, 100156, 100158, 100163, 100166, 100167, 100168, 100170, 100172, 100174, 100175, 100179, 100187, 100188, 100191, 100194, 100198, 100206, 100207, 100209, 100210, 100213, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100230, 100231, 100237, 100244, 100246, 100247, 100248, 100249, 100268, 100269, 100270, 100271, 100275, 100280, 100281, 100290, 100291, 100309, 100316, 100334, 100390, 100395, 100398, 100427, 100430, 100438, 100446, 100460, 100462, 100478, 100482, 100487, 100488, 100493, 100497, 100505, 100509, 100510, 100513, 100514, 100516, 100522, 100527, 100529, 100532, 100537, 100542, 100551, 100555, 100559, 100565, 100567, 100571, 100576, 100578, 100580, 100584, 100585, 100592, 100594, 100598, 100600, 100601, 100606, 100612, 10061…
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-0089-2026 as Class I
type: Claim
text: The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I
  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.