Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
type: Dataset
description: FDA recall Z-2963-2024 — Abiomed, Inc. is recalling Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; (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 Set, US; Product Code: 0550-0008;
  type: MedicalDevice
  manufacturer: Abiomed, Inc.
claims: FDA recall Z-2963-2024: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
claims: FDA classified recall Z-2963-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2963-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2963-2024
      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: 0550-0008; UDI-DI: 00813502011531; Serial Numbers: 387019 388061 388062 388063 388064 388065 387273 388067 388068 387339 387340 387341 387342 387343 388071 388072 388073 388074 388075 388057 388058 388060 387319 387320 387321 387322 387323 383456 383457 383458 388084 383742 383731 384086 387304 387306 387307 387308 383455 383459 388081 388082 388083 388085 388076 388077 388078 388080 384031 384032 384033 384034 384035 383739 383741 383743 383729 383730 388311 388312 388301 388302 388307 383681 388605 388606 388607 388608 388286 388287 388288 388289 388295 388296 388297 388298 388299 388310 388313 388314 388290 388291 388293 388300 388304 388305 388306 388308 388309 389151 389152 388609 388624 388625 389117 389120 388619 388618 388617 388616 388615 388611 388612 388614 389116 389118 389119 389101 389102 389103 389104 389105 388626 388627 388628 388629 388630 388610 388613 389153 389154 389155 389320 389319 389318 389317 389316 389161 389163 389164 389753 389312 389306 389307 389308 389310 389162 389165 389752 389751 389160 389159 389158 389157 389156 389313 389315 389314 389309 389765 390888 387016A 389750 384800A 384618A 384811A 389744 389745 389746 389747 389748 389331 389332 389333 389334 389335 390867 390868 390869 390870 390871 389764 389766 389767 390862 390863 390864 390865 390866 389825 389826 389827 390889 390890 390891 389884 389859 389860 389861 389862 389863 389734 389735 389737 389738 389879 389880 389882 389824 389828 389877 389874 389875 389876 389819 389820 389878 389821 389823 389902 389889 389890 389891 389904 390341 390343 390344 389895 389898 389899 389901 389903 390345 390346 390348 389885 389886 389887 389888 389892 389905 389906 389907 389908 390340 389897 389900 391311 391312 391314 391405 391406 391407 391313 391408 391409 391420 391421 391422 391439 390517 390518 390519 390544 390545 390546 390365 390366 390573 391423 391424 390576 390589 391435 391437 391438 390521 390542 390543 390961 390361 390362 390363 390364 390905 390906…
      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-2963-2024: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
type: Claim
text: The FDA logged enforcement record Z-2963-2024: Abiomed, Inc. is voluntarily recalling Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; — 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: 0550-0008; UDI-DI: 00813502011531; Serial Numbers: 387019 388061 388062 388063 388064 388065 387273 388067 388068 387339 387340 387341 387342 387343 388071 388072 388073 388074 388075 388057 388058 388060 387319 387320 387321 387322 387323 383456 383457 383458 388084 383742 383731 384086 387304 387306 387307 387308 383455 383459 388081 388082 388083 388085 388076 388077 388078 388080 384031 384032 384033 384034 384035 383739 383741 383743 383729 383730 388311 388312 388301 388302 388307 383681 388605 388606 388607 388608 388286 388287 388288 388289 388295 388296 388297 388298 388299 388310 388313 388314 388290 388291 388293 388300 388304 388305 388306 388308 388309 389151 389152 388609 388624 388625 389117 389120 388619 388618 388617 388616 388615 388611 388612 388614 389116 389118 389119 389101 389102 389103 389104 389105 388626 388627 388628 388629 388630 388610 388613 389153 389154 389155 389320 389319 389318 389317 389316 389161 389163 389164 389753 389312 389306 389307 389308 389310 389162 389165 389752 389751 389160 389159 389158 389157 389156 389313 389315 389314 389309 389765 390888 387016A 389750 384800A 384618A 384811A 389744 389745 389746 389747 389748 389331 389332 389333 389334 389335 390867 390868 390869 390870 390871 389764 389766 389767 390862 390863 390864 390865 390866 389825 389826 389827 390889 390890 390891 389884 389859 389860 389861 389862 389863 389734 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-2963-2024 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.