ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
type: Dataset
description: FDA recall Z-0822-2025 — Boston Scientific Corporation is recalling ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) (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: ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0822-2025: Boston Scientific Corporation is recalling ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
claims: FDA classified recall Z-0822-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0822-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0822-2025
      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: L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 101025 101033 101036 101037 101042 101043 101044 101046 101048 101050 101053 101059 101061 101067 101214 101218 101221 101223 101224 101225 101382 101388 101393 101400 101406 101409 101411 101412 101418 101423 101424 101427 101436 101438 101440 101442 101450 101454 101455 101457 101459 101466 101469 101472 101475 101492 101493 101494 101511 101523 101524 101525 101529 101533 101535 101537 101541 101543 101545 101546 101550 101553 101555 101559 101560 101564 101572 101575 101576 101577 101579 101581 101584 101585 101588 101590 101602 101603 101604 101605 101607 101609 101611 101619 101625 101633 101634 101637 101638 101640 101642 101644 101648 101654 101656 101659 101676 101684 101687 101700 101705 101706 101726 101741 101749 101767 101779 101788 101790 101796 101805 101823 101825 101841 101844 101851 101852 101873 101889 101911 101912 101919 101930 101931 101938 101941 101942 101951 101953 101955 101966 101967 101968 101982 101987 101988 101992 101998 102010 102011 102014 102022 102023 102025 102033 102034 102036 102039 102040 102042 102047 102057 102058 102068 102070 102073 102076 102079 102080 102081 102084 102085 102087 102089 102091 102095 102096 102098 102101 102104 102112 102115 102118 102125 102129 102138 102142 102144 102147 102148 102152 102153 102154 102156 102157 102160 102164 102167 102172 102176 102183 102184 102185 102187 102188 102191 102198 102201 102203 102205 102207 102209 102210 102211 102215 102222 102223 102237 102247 102248 102250 102252 102257 102260 102263 102264 102269 102278 102283 102284 102289 102291 102297 102301 102302 102308 102309 102310 102311 102316 102325 102327 102331 102332 102338 102342 102348 102350 102352 102353 102355 102356 102360 102361 102362 102363 102365 102370 10237…
      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-0822-2025: Boston Scientific Corporation is recalling ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
type: Claim
text: The FDA logged enforcement record Z-0822-2025: Boston Scientific Corporation is voluntarily recalling ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) — 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: L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 101025 101033 101036 101037 101042 101043 101044 101046 101048 101050 101053 101059 101061 101067 101214 101218 101221 101223 101224 101225 101382 101388 101393 101400 101406 101409 101411 101412 101418 101423 101424 101427 101436 101438 101440 101442 101450 101454 101455 101457 101459 101466 101469 101472 101475 101492 101493 101494 101511 101523 101524 101525 101529 101533 101535 101537 101541 101543 101545 101546 101550 101553 101555 101559 101560 101564 101572 101575 101576 101577 101579 101581 101584 101585 101588 101590 101602 101603 101604 101605 101607 101609 101611 101619 101625 101633 101634 101637 101638 101640 101642 101644 101648 101654 101656 101659 101676 101684 101687 101700 101705 101706 101726 101741 101749 101767 101779 101788 101790 101796 101805 101823 101825 101841 101844 101851 101852 101873 101889 101911 101912 101919 101930 101931 101938 101941 101942 101951 101953 101955 101966 101967 101968 101982 101987 101988 101992 101998 102010 102011 102014 102022 102023 102025 102033 102034 102036 102039 102040 102042 102047 102057 102058 102068 102070 102073 102076 102079 102080 102081 102084 102085 102087 102089 1…
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-0822-2025 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.