Model Number L210 PROPONENT SR SL Pacemaker
type: Dataset
description: FDA recall Z-0088-2026 — Boston Scientific Corporation is recalling Model Number L210 PROPONENT SR SL 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 L210 PROPONENT SR SL Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0088-2026: Boston Scientific Corporation is recalling Model Number L210 PROPONENT SR SL Pacemaker
claims: FDA classified recall Z-0088-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0088-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0088-2026
      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 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440, 100443, 100460, 100473, 100488, 100491, 100492, 100496, 100502, 100504, 100510, 100526, 100534, 100535, 100536, 100539, 100546, 100547, 100548, 100549, 100551, 100552, 100556, 100561, 100567, 100581, 100584, 100585, 100587, 100588, 100592, 100593, 100598, 100599, 100602, 100604, 100605, 100606, 100610, 100613, 100619, 100623, 100629, 100630, 100634, 100639, 100640, 100644, 100647, 100650, 100653, 100661, 100663, 100666, 100669, 100674, 100681, 100682, 100686, 100688, 100692, 100694, 100696, 100698, 100702, 100708, 100713, 100719, 100720, 100722, 100724, 100728, 100730, 100737, 100742, 100743, 100749, 100750, 100754, 100756, 100757, 100762, 100764, 100765, 100768, 100773, 100774, 100778, 100783, 100785, 100791, 100794, 100797, 100815, 100823, 100826, 100827, 100828, 100831, 100832, 100839, 100840, 100841, 100847, 100848, 100853, 100854, 100855, 100856, 100860, 100861, 100864, 100885, 100886, 100887, 100899, 100902, 100905, 100906, 100907, 100908, 100917, 100920, 100921, 100928, 100929, 100934, 100937, 100938, 100940, 100941, 100943, 100944, 100949, 100951, 100956, 100957, 100960, 100962, 100…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0088-2026: Boston Scientific Corporation is recalling Model Number L210 PROPONENT SR SL Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0088-2026: Boston Scientific Corporation is voluntarily recalling Model Number L210 PROPONENT SR SL 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 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440, 100443, 100460, 100473, 100488, 100491, 100492, 100496, 100502, 100504, 100510, 100526, 100534, 100535, 100536, 100539, 100546, 100547, 100548, 100549, 100551, 100552, 100556, 100561, 100567, 100581, 100584, 100585, 100587, 100588, 100592, 100593, 100598, 100599, 100602, 100604, 100605, 100606, 100610, 100613, 100619, 100623, 100629, 100630, 100634, 100639, 100640, 100644, 100647, 100650, 100653, 100661, 100663, 100666, 100669, …
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-0088-2026 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.