Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
type: Dataset
description: FDA recall Z-1695-2024 — Abbott Medical is recalling Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO (Devices, Class II). 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: Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
  type: MedicalDevice
  manufacturer: Abbott Medical
claims: FDA recall Z-1695-2024: Abbott Medical is recalling Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
claims: FDA classified recall Z-1695-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1695-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1695-2024
      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 II
      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: Abbott Medical
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-02-05
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301916 1301963 1301912 1301968 524931 1304777 1301964 1304509 1304507 1302859 1304519 1304791 1304828 1304815 1304821 1304823 1304824 1304522 1304822 1304820 1304829 1304805 1304835 1304836 1304834 1304841 1304837 1304788 1304797 1304802 1304799 1304845 1304854 1304846 1304857 1304852 1304847 1304858 1304868 1304866 1304862 1304870 1304864 1304859 1304856 1304899 1304945 1304959 1304918 1304957 1304906 1304949 1304933 1304911 1304960 1304958 1304903 1304927 1304908 1304919 1304901 1304968 1304962 1304920 1304997 1304931 1305002 1305007 1304884 1304993 1304977 1305000 1304991 1304998 1304994 1304996 1304956 1304982 1304978 1304989 1304990 1304980 1304983 1304984 1304981 1304988 1305018 1305026 1305023 1305010 1305034 1305012 1305005 1305014 1305061 1305083 1305052 1305011 1305084 1305045 1305044 1305040 1305047 1305041 1305053 1305060 1305057 1305043 1305042 1305046 1305054 1305079 1305076 1305068 1305088 1305086 1305056 1305077 1305072 1305069 1305070 1305071 1305074 1305024 1305033 1305067 1305080 1305073 1305062 1305021 1305085 1305173 1305171 1305183 1305172 1305170 1305182 1305236 1305178 1305227 1305176 1305211 1305174 1305180 1305223 1305234 1305230 1305204 1305181 1305224 1305179 1305237 1305203 1305218 1305177 1305175 1305196 1305184 1305215 1305208 1305209 1305219 1305229 1305210 1305217 1305222 1305059 1305442 1305467 1305441 1305435 1305443 1305448 1305463 1305447 1305437 1305438 1305434 1305469 1305445 1305439 1305466 1305461 1305444 1305440 1305462 1305470 1305602 1305647 1305619 1305597 1305624 1305598 1305607 1305618 1305653 1305646 1305660 1305649 1305662 1305655 1305650 1305665 1305658 1305659 1305636 1305669 1305657 1305664 1305465 1305654 1305651 1305617 1306093 1306091 1306111 1306099 1305635 1305663 1306112 1305671 1306081 1306094 1306088 1306090 1306076 1306101 1306085 1306116 1305468 1306105 1306113 1306077 1306082 1306083 130610…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending
      status: recorded

FDA recall Z-1695-2024: Abbott Medical is recalling Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
type: Claim
text: The FDA logged enforcement record Z-1695-2024: Abbott Medical is voluntarily recalling Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO — reason: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-05. Affected lots/codes: UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301916 1301963 1301912 1301968 524931 1304777 1301964 1304509 1304507 1302859 1304519 1304791 1304828 1304815 1304821 1304823 1304824 1304522 1304822 1304820 1304829 1304805 1304835 1304836 1304834 1304841 1304837 1304788 1304797 1304802 1304799 1304845 1304854 1304846 1304857 1304852 1304847 1304858 1304868 1304866 1304862 1304870 1304864 1304859 1304856 1304899 1304945 1304959 1304918 1304957 1304906 1304949 1304933 1304911 1304960 1304958 1304903 1304927 1304908 1304919 1304901 1304968 1304962 1304920 1304997 1304931 1305002 1305007 1304884 1304993 1304977 1305000 1304991 1304998 1304994 1304996 1304956 1304982 1304978 1304989 1304990 1304980 1304983 1304984 1304981 1304988 1305018 1305026 1305023 1305010 1305034 1305012 1305005 1305014 1305061 1305083 1305052 1305011 1305084 1305045 1305044 1305040 1305047 1305041 1305053 1305060 1305057 1305043 1305042 1305046 1305054 1305079 1305076 1305068 1305088 1305086 1305056 1305077 1305072 1305069 1305070 1305071 1305074 1305024 1305033 1305067 1305080 1305073 1305062 1305021 1305085 1305173 1305171 1305183 1305172 1305170 1305182 1305236 1305178 1305227 1305176 1305211 1305174 1305180 1305223 1305234 1305230 1305204 1305181 1305224 1305179 1305237 1305203 1305218 1305177 1305175 1305196 1305184 1305215 1305208 1305209 1305219 1305229 1305210 1305217 1305222 1305059 1305442 1305467 1305441 1305435 1305443 1305448 1305463 1305447 1305437 1305438 1305434 1305469 1305445 1305439 1305466 1305461 1305444 1305440 1305462 1305470 1305602 1305647 1305619…
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-1695-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. 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 II
  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.