VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
type: Dataset
description: FDA recall Z-0826-2025 — Boston Scientific Corporation is recalling VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) (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: VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
  type: MedicalDevice
  manufacturer: Boston Scientific Corporation
claims: FDA recall Z-0826-2025: Boston Scientific Corporation is recalling VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
claims: FDA classified recall Z-0826-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0826-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0826-2025
      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: U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319 100323 100329 100331 100333 100379 100380 100384 100385 100386 100390 100392 100439 100448 100452 100453 100462 100466 100467 100480 100481 100482 100485 100486 100495 100496 100497 100498 100499 100500 100502 100505 100506 100510 100514 100515 100517 100518 100524 100526 100539 100540 100541 100546 100548 100549 100552 100585 100650 100653 100656 100657 100658 100690 100692 100693 100697 100699 100700 100701 100703 100707 100711 100716 100721 100722 100723 100725 100726 100730 100731 100733 100735 100740 100743 100746 100748 100751 100754 100755 100756 100757 100758 100759 100760 100761 100763 100764 100767 100768 100770 100772 100774 100775 100776 100777 100778 100779 100780 100781 100784 100786 100788 100789 100790 100792 100793 100799 100801 100802 100803 100805 100813 100814 100818 100823 100830 100833 100843 100846 100854 100864 100866 100870 100871 100873 100877 100884 100886 100891 100910 100912 700042 700066 700191 700272 700277 700306 700507 700582 700630 700713 700726 700735 700762 700796 700801 700802 700805 700820 700832 700834 700837 700839 700852 700853 700854 700856 700860 700863 700867 700985 701002 701003 701008 701015 701023 701033 701060 701104 701156 701168 701232 701485 701520 701560 701562 701563 701564 701566 701569 701570 701571 701573 701574 701579 701580 701586 701587 701593 701599 701600 701601 701603 701604 701606 701609 701612 701613 701616 701617 701618 701620 701623 701624 701625 701626 701645 701646 701647 701648 701649 701650 701651 701653 701655 701656 701657 701659 701662 701675 701676 701678 701684 701691 701692 701693 701696 701697 701699 701700 701701 701702 701703 701704 701705 701707 701709 701710 701713 701718 701720 701722 701724 701725 701726 701729 701733 701739 701741 701742 701745 701746 701750 701751 701752 701754 701755 701757 701761 701763 701764 701765 701766 701767 701770 701771 701772 701774 701780…
      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-0826-2025: Boston Scientific Corporation is recalling VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
type: Claim
text: The FDA logged enforcement record Z-0826-2025: Boston Scientific Corporation is voluntarily recalling VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) — 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: U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319 100323 100329 100331 100333 100379 100380 100384 100385 100386 100390 100392 100439 100448 100452 100453 100462 100466 100467 100480 100481 100482 100485 100486 100495 100496 100497 100498 100499 100500 100502 100505 100506 100510 100514 100515 100517 100518 100524 100526 100539 100540 100541 100546 100548 100549 100552 100585 100650 100653 100656 100657 100658 100690 100692 100693 100697 100699 100700 100701 100703 100707 100711 100716 100721 100722 100723 100725 100726 100730 100731 100733 100735 100740 100743 100746 100748 100751 100754 100755 100756 100757 100758 100759 100760 100761 100763 100764 100767 100768 100770 100772 100774 100775 100776 100777 100778 100779 100780 100781 100784 100786 100788 100789 100790 100792 100793 100799 100801 100802 100803 100805 100813 100814 100818 100823 100830 100833 100843 100846 100854 100864 100866 100870 100871 100873 100877 100884 100886 100891 100910 100912 700042 700066 700191 700272 700277 700306 700507 700582 700630 700713 700726 700735 700762 700796 700801 700802 700805 700820 700832 700834 700837 700839 700852 700853 700854 700856 700860 700863 700867 700985 701002 701003 701008 701015 701023 701033 701060 701104 701156 701168 701232 701485 701520 701560 701562 701563 701564 701566 701569 701570 701571 701573 701574 701579 701580 701586 701587 701593 701599 701600 701601 701603…
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-0826-2025 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.