PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
type: Dataset
description: FDA recall Z-0823-2025 — Boston Scientific Corporation is recalling PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). (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: PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: enforcement-record
claims: FDA classified recall Z-0823-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0823-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0823-2025
      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 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: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-12-12
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 715934 715949 715953 715981 715986 715991 715993 716002 716005 716007 716011 716016 716028 716044 716045 716054 716063 716066 716081 716097 716106 716147 716148 716162 716163 716171 716182 716183 716190 716194 716205 716208 716228 716237 716239 716247 716250 716255 716256 716260 716267 716282 716288 716289 716290 716291 716292 716306 716309 716315 716317 716333 716342 716346 716360 716375 716380 716396 716407 716410 716419 716421 716423 716424 716426 716433 716435 716443 716455 716473 716514 716543 716545 716572 716605 716610 716629 716641 716680 716715 716721 716727 716750 716759 716760 716769 716779 716803 716836 716839 716841 716845 716868 716990 716994 716997 717000 717009 717018 717034 717040 717053 717070 717083 717098 717099 717108 717118 717124 717153 717156 717166 717182 717189 717197 717248 717250 717274 717302 717306 717310 717313 717314 717369 717378 717413 717491 717525 717533 717570 717577 717583 717593 717600 717700 717816 717877 717878 717885 717896 717906 717917 717931 717963 717978 717991 717994 717996 718005 718021 718137 718242 718418 718492 718494 718504 718528 718552 718558 718600 718601 718605 718608 718617 718627 718630 718631 718640 718659 718667 718668 718672 718675 718676 718680 718683 718697 718705 718711 718713 718716 718733 718743 718747 718748 718762 718775 718778 718784 718794 718801 718805 718806 718807 718820 718831 718833 718852 718860 718868 718881 718882 718883 718890 718892 718893 718894 718896 718900 718901 718908 718914 718915 718931 718972 718979 718989 718990 719003 719014 719016 719045 719948 723990 724576 724581 724583 724597 724612 724614 724616 724619 724620 724640 724644 724645 724654 724658 724663 724664 724665 724666 724670 724671 72…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0823-2025: Boston Scientific Corporation is recalling PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
text: The FDA logged enforcement record Z-0823-2025: Boston Scientific Corporation is voluntarily recalling PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). — reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-12. Affected lots/codes: L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 715934 715949 715953 715981 715986 715991 715993 716002 716005 716007 716011 716016 716028 716044 716045 716054 716063 716066 716081 716097 716106 716147 716148 716162 716163 716171 716182 716183 716190 716194 716205 716208 716228 716237 716239 716247 716250 716255 716256 716260 716267 716282 716288 716289 716290 716291 716292 716306 716309 716315 716317 716333 716342 716346 716360 716375 716380 716396 716407 716410 716419 716421 716423 716424 716426 716433 716435 716443 716455 716473 716514 716543 716545 716572 716605 716610 716629 716641 716680 716715 716721 716727 716750 716759 716760 716769 716779 716803 716836 716839 716841 716845 716868 716990 716994 716997 717000 717009 717018 717034 717040 717053 717070 717083 717098 717099 717108 717118 717124 717153 717156 717166 717182 717189 717197 717248 717250 717274 717302 717306 717310 717313 717314 717369 717378 717413 717491 717525 717533 717570 717577 717583 717593 717600 717700 717816 717877 717878 717885 717896 717906 717917 717931 717963 717978 717991 717994 717996 718005 718021 718137 718242 718418 718492 718494 7…
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-0823-2025 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.