ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
type: Dataset
description: FDA recall Z-0824-2025 — Boston Scientific Corporation is recalling ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131) (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: ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0824-2025: Boston Scientific Corporation is recalling ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
claims: FDA classified recall Z-0824-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0824-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0824-2025
      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: L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697 100701 100702 100703 100705 100706 100723 100724 100726 100727 100735 100740 100741 100762 100792 101029 101217 101364 101367 101370 101385 101392 101404 101408 101425 101428 101441 101480 101498 101499 101512 101558 101566 101570 101578 101595 101624 101673 101680 101694 101716 101721 101724 101731 101732 101742 101747 101757 101774 101775 101777 101784 101793 101799 101801 101810 101813 101830 101832 101836 101845 101854 101859 101860 101861 101863 101865 101870 101871 101874 101880 101898 101902 101903 101914 101921 101933 101936 101939 101950 101952 101956 101960 101961 101969 101971 101976 101993 102000 102001 102005 102021 102029 102037 102038 102041 102046 102060 102062 102069 102075 102077 102099 102103 102120 102127 102168 102174 102181 102212 102219 102225 102234 102249 102272 102275 102402 102403 102412 102433 102457 102466 102504 102537 102541 102568 102600 102607 102615 102616 102627 102645 102648 102650 102660 102679 102681 102684 102686 102693 102698 102707 102722 102723 102747 102749 102754 102757 102758 102763 102772 102784 102790 102793 102804 102807 102809 102813 102818 102819 102824 102831 102835 102849 102851 102857 102905 102918 102932 102934 102938 102939 102940 102941 102947 102951 102972 102975 102982 102983 102989 102995 103004 103006 103015 103017 103020 103081 103083 103095 103102 103106 103116 103120 103127 103135 103145 103147 103151 103156 103157 103162 103171 103178 103179 103186 103188 103192 103194 103197 103217 103220 103223 103235 103237 103238 103240 103242 103245 103246 103250 103251 103253 103256 103263 103266 103287 700047 700056 700058 700064 700066 700067 700072 700073 700074 700076 700080 700083 700090 700104 700105 700117 700161 700206 700207 700236 700284 700295 700331 700338 700383 700386 700397 700400 700441 700481 700482 700506 700548 700549 700550 700637 700645 700651 700764 700769 700779 700789 70079…
      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

FDA recall Z-0824-2025: Boston Scientific Corporation is recalling ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
type: Claim
text: The FDA logged enforcement record Z-0824-2025: Boston Scientific Corporation is voluntarily recalling ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131) — 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: L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697 100701 100702 100703 100705 100706 100723 100724 100726 100727 100735 100740 100741 100762 100792 101029 101217 101364 101367 101370 101385 101392 101404 101408 101425 101428 101441 101480 101498 101499 101512 101558 101566 101570 101578 101595 101624 101673 101680 101694 101716 101721 101724 101731 101732 101742 101747 101757 101774 101775 101777 101784 101793 101799 101801 101810 101813 101830 101832 101836 101845 101854 101859 101860 101861 101863 101865 101870 101871 101874 101880 101898 101902 101903 101914 101921 101933 101936 101939 101950 101952 101956 101960 101961 101969 101971 101976 101993 102000 102001 102005 102021 102029 102037 102038 102041 102046 102060 102062 102069 102075 102077 102099 102103 102120 102127 102168 102174 102181 102212 102219 102225 102234 102249 102272 102275 102402 102403 102412 102433 102457 102466 102504 102537 102541 102568 102600 102607 102615 102616 102627 102645 102648 102650 102660 102679 102681 102684 102686 102693 102698 102707 102722 102723 102747 102749 102754 102757 102758 102763 102772 102784 102790 102793 102804 102807 102809 102813 102818 102819 102824 102831 102835 102849 102851 102857 102905 102918 102932 102934 102938 102939 102940 102941 102947 102951 102972 102975 102982 102983 102989 102995 103004 103006 103015 10…
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-0824-2025 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.