Model Number L221 PROPONENT DR EL Pacemaker
type: Dataset
description: FDA recall Z-0090-2026 — Boston Scientific Corporation is recalling Model Number L221 PROPONENT DR EL 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 L221 PROPONENT DR EL Pacemaker
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0090-2026: Boston Scientific Corporation is recalling Model Number L221 PROPONENT DR EL Pacemaker
claims: FDA classified recall Z-0090-2026 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0090-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0090-2026
      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 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491, 723494, 723498, 723509, 723529, 723557, 723559, 723562, 723573, 723625, 724616, 724666, 724696, 724709, 724782, 724819, 724838, 724846, 724853, 724857, 724890, 724914, 725181, 725182, 725183, 725184, 725185, 725186, 725187, 725188, 725189, 725190, 725586, 725603, 725604, 725605, 725607, 725608, 725609, 725610, 725727, 725792, 725801, 726384, 726419, 726545, 726800, 726801, 726878, 727128, 727172, 727178, 727236, 727242, 727255, 727257, 727262, 727263, 727268, 727271, 727292, 727315, 727323, 727335, 727346, 727376, 727378, 727379, 727382, 728093, 728135, 728139, 728153, 728301, 728324, 728381, 728658, 728682, 728690, 728694, 728713, 728881, 728905, 728908, 728911, 728967, 728981, 728982, 729013, 729066, 729068, 729069, 729071, 729075, 729081, 729083, 729237, 729258, 729321, 729323, 729340, 729390, 729736, 730067, 730087, 730237, 730238, 730239, 731097, 731100, 731104, 731106, 731110, 731118, 731150, 731166, 731168, 731198, 731279, 731294, 731306, 733065, 733285, 733332, 733838, 734232, 734237, 734238, 734261, 735042. GTIN 00802526578045, Serial Numbers: 100200, 100307, 100313, 100316, 1003…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0090-2026: Boston Scientific Corporation is recalling Model Number L221 PROPONENT DR EL Pacemaker
type: Claim
text: The FDA logged enforcement record Z-0090-2026: Boston Scientific Corporation is voluntarily recalling Model Number L221 PROPONENT DR EL 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 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491, 723494, 723498, 723509, 723529, 723557, 723559, 723562, 723573, 723625, 724616, 724666, 724696, 724709, 724782, 724819, 724838, 724846, 724853, 724857, 724890, 724914, 725181, 725182, 725183, 725184, 725185, 725186, 725187, 725188, 725189, 725190, 725586, 725603, 725604, 725605, 725607, 725608, 725609, 725610, 725727, 725792, 725801, 726384, 726419, 726545, 726800, 726801, 726878, 727128, 727172, 727178, 727236, 727242, 727255…
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-0090-2026 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.