Z-1223-2023.jsonld
type: Dataset
name: CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
description: FDA recall Z-1223-2023 — St. Jude Medical is recalling CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment. (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: CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
  manufacturer: St. Jude Medical
claims: enforcement-record
claims: FDA classified recall Z-1223-2023 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1223-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1223-2023
      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: St. Jude Medical
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-02-07
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI/DI 05414734509237, Serial numbers: H24Y92, H24YB8, H24YJY, H24YSK, H24YY9, H24YZG, H24Z3B, H24Z8S, H24ZEE, H24ZF7, H24ZHH, H24ZMN, H24ZTV, H24ZVP, H24ZWL, K24YFW, K25YCE, K25YEY, K25YKN, K25Z4K, K26WLC, K26WN6, K26WT4, K26WVE, K26WY3, K26WZA, K26X2N, K26X48, K26X53, K26X6A, K26X7H, K26X84, K26X97, K26XEQ, K26XGS, K26XHP, K26XJV, K26XKW, K26XLB, K26XMG, K26XN9, K26XPX, K26XQU, K26XVH, K26XWA, K26XY4, K27VK3, K27VNU, K27VP2, K27VQ9, K27VUV, K27VWP, K27W2W, K27W5B, K27W8C, K27W9F, K27WA4, K27WBD, K27WNH, K27WQL, K27X2Z, K27X4F, K27XGM, L23YVM, L23YXT, L23YYY, L23YZR, L23Z3J, L23ZAB, L23ZDL, L23ZEP, L23ZFW, L23ZHQ, L23ZN6, L23ZRJ, L23ZZA, L24262, L2428C, L2429F, L242A4, L242BD, L242CE, L242EY, L242JM, L24XVJ, L24Y4E, L24Y5D, L24Y64, L24Y8A, L24YA2, L24YBB, L24YKQ, L24YM6, L24YQJ, L24YRT, L24YSY, L24YXH, L24YYA, L24Z38, L24Z4M, L24Z6X, L24Z8R, L24ZE5, L24ZFC, L24ZJG, L24ZKB, L24ZMV, L24ZUM, L25X6W, L25XD7, L25XE4, L25XGE, L25XJH, L25XLX, L25XMU, L25XNM, L25XQG, L25XR9, L25XTP, L25XUL, L25XVV, L25XXK, L25XYQ, L25XZZ, L25Y3L, L25Y52, L25Y7G, L25YAD, L25YB4, L25YDJ, L25YFY, L25YGT, L25YHN, L25YRL, L25YSP, L25YT2, L25YU9, L25YVG, L25Z2C, L25Z4S, L25Z5Z, L26WBB, L26WCG, L26WDV, L26WFP, L26WGL, L26WL5, L26WM6, L26WNF, L26WPR, L26WRT, L26WSY, L26WV7, L26WXH, L26WYA, L26X2X, L26X3U, L26X4H, L26X5A, L26XA5, L26XL2, L26XM9, L26XSX, L26XW3, L26Y5X, L26Y8Y, L27VVV, L27VYQ, L27W7G, L27WMH, L27WZC, L27X55, L27X7F, L27X82, L27X99, L27XDM, L27XJT, L28UW6, L28V5L, L28V9Q, L28VCR, L28VE7, L28VMX, L28VS9, L28VUP, L28VWV, L28VXQ, L28VYK, L28VZS, L28W2L, L28W59, L28W95, L28WDR, L28WKU, L28WN3, L28WQW, L28WRP, L29UB6, L29UDQ, L29UFS, L29UHL, L29UJW, L29UMB, L29UN2, L29URN, L29USM, L29UX4, L29UY7, L29UZE, L29V3D, L29V4Y, L29V5T, L29V7R, L29V9X, L29VAL, L29VBV, L29VDB, L29VEG, L29VG2, L29VHF, L29VLK, L29VMQ, L29VNZ, L29VP7, L29VQ4, L29VRD, L29VXX, L2ATFV, L2ATJZ, L2ATLF, L2ATPT, L2ATQY, L2ATSJ, L2ATT7, L2ATZH, L2AU34, L2AU4R, L2AU8M, L2AUGB, L2AUH6, L2AULS, L2AUMZ, L2AUNQ, L2AUPE, L2AUUR, L…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1223-2023: St. Jude Medical is recalling CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
text: The FDA logged enforcement record Z-1223-2023: St. Jude Medical is voluntarily recalling CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment. — reason: Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-07. Affected lots/codes: UDI/DI 05414734509237, Serial numbers: H24Y92, H24YB8, H24YJY, H24YSK, H24YY9, H24YZG, H24Z3B, H24Z8S, H24ZEE, H24ZF7, H24ZHH, H24ZMN, H24ZTV, H24ZVP, H24ZWL, K24YFW, K25YCE, K25YEY, K25YKN, K25Z4K, K26WLC, K26WN6, K26WT4, K26WVE, K26WY3, K26WZA, K26X2N, K26X48, K26X53, K26X6A, K26X7H, K26X84, K26X97, K26XEQ, K26XGS, K26XHP, K26XJV, K26XKW, K26XLB, K26XMG, K26XN9, K26XPX, K26XQU, K26XVH, K26XWA, K26XY4, K27VK3, K27VNU, K27VP2, K27VQ9, K27VUV, K27VWP, K27W2W, K27W5B, K27W8C, K27W9F, K27WA4, K27WBD, K27WNH, K27WQL, K27X2Z, K27X4F, K27XGM, L23YVM, L23YXT, L23YYY, L23YZR, L23Z3J, L23ZAB, L23ZDL, L23ZEP, L23ZFW, L23ZHQ, L23ZN6, L23ZRJ, L23ZZA, L24262, L2428C, L2429F, L242A4, L242BD, L242CE, L242EY, L242JM, L24XVJ, L24Y4E, L24Y5D, L24Y64, L24Y8A, L24YA2, L24YBB, L24YKQ, L24YM6, L24YQJ, L24YRT, L24YSY, L24YXH, L24YYA, L24Z38, L24Z4M, L24Z6X, L24Z8R, L24ZE5, L24ZFC, L24ZJG, L24ZKB, L24ZMV, L24ZUM, L25X6W, L25XD7, L25XE4, L25XGE, L25XJH, L25XLX, L25XMU, L25XNM, L25XQG, L25XR9, L25XTP, L25XUL, L25XVV, L25XXK, L25XYQ, L25XZZ, L25Y3L, L25Y52, L25Y7G, L25YAD, L25YB4, L25YDJ, L25YFY, L25YGT, L25YHN, L25YRL, L25YSP, L25YT2, L25YU…
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-1223-2023 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.