Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
type: Dataset
description: FDA recall Z-2965-2024 — Abiomed, Inc. is recalling Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; (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 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
  type: MedicalDevice
  manufacturer: Abiomed, Inc.
claims: FDA recall Z-2965-2024: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
claims: FDA classified recall Z-2965-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2965-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2965-2024
      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: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054 417056 417057 417058 417819 417821 417042 416991 417043 417024 417025 417026 417027 417028 417234 417235 417236 416989 416990 416992 416993 417040 417041 416864 416865 416866 416867 416962 416959 416887 416888 416963 417237 417238 416897 416869 416872 416873 416886 416961 416960 417833 416870 416871 416855 416854 416858 417244 417246 417245 416884 416885 417061 417062 417063 417815 417269 417270 417271 417272 417785 417786 417768 417769 417770 417771 417239 417240 417242 417243 417060 417247 417808 417809 417811 417814 417273 417782 417783 417784 417937 417938 417939 417940 417941 417498 417264 417265 417266 417267 417268 417955 417956 417494 417495 417465 417466 417467 418015 418018 418019 417816 417952 417953 417954 417497 417464 418016 418017 418732 418733 418715 418716 418717 418718 417496 418700 418701 418702 416859 416860 416861 416862 416863 418729 418730 417249 417250 417251 417252 419011 418699 418703 418175 418176 418177 418731 420411 418744 418745 418746 418253 420973 420985 420986 420987 420988 420989 418170 418172 418020 418021 420410 418747 418748 418249 418250 418251 418252 418022 418024 420974 419093 419094 419095 419096 419097 418256 418257 420441 420442 420412 420413 418053 418054 420445 420446 420447 420448 418254 418255 417604 417605 417606 417607 417608 417659 418154 418157 417660 417661 417662 417663 420414 418050 418051 418052 420535 420525 420527 420526 418258 418811 418856 418857 418858 420990 420992 418972 420991 420994 418973 418974 418975 418976 420530 420531 420532 420533 420425 417482 417483 417973 417974 420534 420426 420427 420428 420429 418049 417590 417591 417592 417593 417480 417481 417509 417510 417512 417513 418143 418135 418136 418138 418045 418046 418047 418048 417468 417589 416857 416856 419012 419013 419014 419015 418141 417832 417836 420538 420539 420662 420663 420540 420542 420626 420627 420628 421156 42115…
      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-2965-2024: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
type: Claim
text: The FDA logged enforcement record Z-2965-2024: Abiomed, Inc. is voluntarily recalling Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; — 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: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054 417056 417057 417058 417819 417821 417042 416991 417043 417024 417025 417026 417027 417028 417234 417235 417236 416989 416990 416992 416993 417040 417041 416864 416865 416866 416867 416962 416959 416887 416888 416963 417237 417238 416897 416869 416872 416873 416886 416961 416960 417833 416870 416871 416855 416854 416858 417244 417246 417245 416884 416885 417061 417062 417063 417815 417269 417270 417271 417272 417785 417786 417768 417769 417770 417771 417239 417240 417242 417243 417060 417247 417808 417809 417811 417814 417273 417782 417783 417784 417937 417938 417939 417940 417941 417498 417264 417265 417266 417267 417268 417955 417956 417494 417495 417465 417466 417467 418015 418018 418019 417816 417952 417953 417954 417497 417464 418016 418017 418732 418733 418715 418716 418717 418718 417496 418700 418701 418702 416859 416860 416861 416862 416863 418729 418730 417249 417250 417251 417252 419011 418699 418703 418175 418176 418177 418731 420411 418744 418745 418746 418253 420973 420985 420986 420987 420988 420989 418170 418172 418020 418021 420410 418747 418748 418249 418250 418251 418252 418022 418024 420974 419093 419094 419095 419096 419097 418256 418257 420441 420442 420412 420413 418053 418054 420445 420446 420447 420448 418254 418255 417604 417605 417606 417607 417608 …
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-2965-2024 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.