Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
type: Dataset
description: FDA recall Z-2955-2024 — Abiomed, Inc. is recalling Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; (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: Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
  type: MedicalDevice
  manufacturer: Abiomed, Inc.
claims: FDA recall Z-2955-2024: Abiomed, Inc. is recalling Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
claims: FDA classified recall Z-2955-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2955-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2955-2024
      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: Abiomed, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-08-05
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Product Code: 0048-0024-JP; UDI-DI: 00813502011609; Serial Numbers: 353552 376694 381128 383037 383039 383040 383041 383042 383043 383044 383045 383046 382465 382467 382468 382469 382470 382472 382136 382138 381247A 379963A 382779 382780 382781 375895 383330 382466 382782 382784 382787 384202 384201 383804 383806 382783 383808 383809 385265 385266 385272 386835 383810 373929 381881 385218 385220 385223 385270 385219 371886 375943 382788 382789 382790 382792 382793 372575 375208 382794 382795 382796 385724 385726 385727 385728 385721 385723 374156 378689 384134 384138 384139 385526 385528 384132 376414 381123 381859 382132 381869A 382785 384140 385530 385531 382786 385532 384207 384210 384684 384687 384688 384689 384128 384692 384126 375207 382130 383813 385527 385529 385534 384123 374157 369021 379105 383811 384133 385729 385730 384693 386201 386202 386207 386209 384983 384981 384980 386032 387077 387085 370796 383812 385525 386204 386210 386033 384204 384205 384209 384685 387078 387079 387081 387082 387083 385271 385274 386845 386848 386850 386851 386846 384127 386026 386837 386839 384984 386853 386836 386838 384987 384988 386841 386843 378895 386840 378894 382464 385722 386203 386030 385268 385269 385273 386834 378896 378900 378901 378902 379404 378903 388236 388237 388238 388239 388242 388243 388245 382454 382455 382457 382458 382459 388241 388244 382460 384729 384730 384732 384733 384734 384735 384737 384738 387814 387813 387801 387799 387798 387797 387796 387793 387792 387811 387810 387808 387807 387806 387795 387794 387809 384979 387805 387803 387802 388919 388922 388921 387804 388917 384137 388920 388916 387817 387819 387815 387816 387818 385533 384203 384686 387086 387800 384208 388918 384206 386205 386206 386029 387820 388026 388028 388029 388033 389185 389184 387821 384124 386028 385217 388027 389183 389181 389180 389179 389178 389546 389177 389176 389544 385215 389545 389547 389548 389552 389553 388913 389909 383560 383562 383563 383564 383569 383565 3835…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.
      status: recorded

FDA recall Z-2955-2024: Abiomed, Inc. is recalling Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
type: Claim
text: The FDA logged enforcement record Z-2955-2024: Abiomed, Inc. is voluntarily recalling Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; — reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-05. Affected lots/codes: Product Code: 0048-0024-JP; UDI-DI: 00813502011609; Serial Numbers: 353552 376694 381128 383037 383039 383040 383041 383042 383043 383044 383045 383046 382465 382467 382468 382469 382470 382472 382136 382138 381247A 379963A 382779 382780 382781 375895 383330 382466 382782 382784 382787 384202 384201 383804 383806 382783 383808 383809 385265 385266 385272 386835 383810 373929 381881 385218 385220 385223 385270 385219 371886 375943 382788 382789 382790 382792 382793 372575 375208 382794 382795 382796 385724 385726 385727 385728 385721 385723 374156 378689 384134 384138 384139 385526 385528 384132 376414 381123 381859 382132 381869A 382785 384140 385530 385531 382786 385532 384207 384210 384684 384687 384688 384689 384128 384692 384126 375207 382130 383813 385527 385529 385534 384123 374157 369021 379105 383811 384133 385729 385730 384693 386201 386202 386207 386209 384983 384981 384980 386032 387077 387085 370796 383812 385525 386204 386210 386033 384204 384205 384209 384685 387078 387079 387081 387082 387083 385271 385274 386845 386848 386850 386851 386846 384127 386026 386837 386839 384984 386853 386836 386838 384987 384988 386841 386843 378895 386840 378894 382464 385722 386203 386030 385268 385269 385273 386834 378896 378900 378901 378902 379404 378903 388236 388237 388238 388239 388242 388243 388245 382454 382455 382457 382458 382459 388241 388244 382460 384729 384730 384732 384733 384734 38…
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-2955-2024 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.