Z-2945-2024.jsonld
type: Dataset
name: Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
description: FDA recall Z-2945-2024 — W L Gore & Associates, Inc. is recalling Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J (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: MedicalDevice
  name: Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
  manufacturer: W L Gore & Associates, Inc.
claims: enforcement-record
claims: FDA classified recall Z-2945-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2945-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2945-2024
      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: W L Gore & Associates, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to packaging defects, sterility assurance and heparin activity may be compromised.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-07-01
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Lot Serial Number/UDI: 27884430 00733132658251 27884431 00733132658251 27884432 00733132658251 27884433 00733132658251 27884434 00733132658251 27884435 00733132658251 27884436 00733132658251 27884437 00733132658251 27884438 00733132658251 27884439 00733132658251 27884440 00733132658251 27884441 00733132658251 27884442 00733132658251 27884443 00733132658251 27884444 00733132658251 27884445 00733132658251 28325852 00733132658251 28325853 00733132658251 28325854 00733132658251 28325856 00733132658251 28325857 00733132658251 28431071 00733132658251 28431072 00733132658251 28431073 00733132658251 28547558 00733132658251 28547559 00733132658251 28547560 00733132658251 28691206 00733132658251 28691207 00733132658251 28691208 00733132658251 28691209 00733132658251 28928606 00733132658251 28928607 00733132658251 28928608 00733132658251 28928609 00733132658251 28928610 00733132658251 28928611 00733132658251 28928612 00733132658251 28928613 00733132658251 28961589 00733132658251 28961590 00733132658251 28961591 00733132658251 29039475 00733132658251 29039476 00733132658251 29039477 00733132658251 29039478 00733132658251 29039479 00733132658251 28356298 00733132658268 27713024 00733132658268 27713025 00733132658268 27713026 00733132658268 27713027 00733132658268 27713028 00733132658268 27713029 00733132658268 27713030 00733132658268 27713031 00733132658268 27713032 00733132658268 27713033 00733132658268 27713034 00733132658268 27713035 00733132658268 27713036 00733132658268 27713037 00733132658268 27713038 00733132658268 27713039 00733132658268 27713040 00733132658268 27713041 00733132658268 27713042 00733132658268 27713043 00733132658268 27713044 00733132658268 27713045 00733132658268 27713046 00733132658268 27713047 00733132658268 27713048 00733132658268 27713049 00733132658268 27713050 00733132658268 27713052 00733132658268 27713053 00733132658268 27713054 00733132658268 27713055 00733132658268 27713056 00733132658268 27713057 00733132658268 27713058 00733132658268 27713059 …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution including in the states of AK, 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, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2945-2024: W L Gore & Associates, Inc. is recalling Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
text: The FDA logged enforcement record Z-2945-2024: W L Gore & Associates, Inc. is voluntarily recalling Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J — reason: Due to packaging defects, sterility assurance and heparin activity may be compromised.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-01. Affected lots/codes: Lot Serial Number/UDI: 27884430 00733132658251 27884431 00733132658251 27884432 00733132658251 27884433 00733132658251 27884434 00733132658251 27884435 00733132658251 27884436 00733132658251 27884437 00733132658251 27884438 00733132658251 27884439 00733132658251 27884440 00733132658251 27884441 00733132658251 27884442 00733132658251 27884443 00733132658251 27884444 00733132658251 27884445 00733132658251 28325852 00733132658251 28325853 00733132658251 28325854 00733132658251 28325856 00733132658251 28325857 00733132658251 28431071 00733132658251 28431072 00733132658251 28431073 00733132658251 28547558 00733132658251 28547559 00733132658251 28547560 00733132658251 28691206 00733132658251 28691207 00733132658251 28691208 00733132658251 28691209 00733132658251 28928606 00733132658251 28928607 00733132658251 28928608 00733132658251 2892860…
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-2945-2024 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.