Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
type: Dataset
description: FDA recall Z-2961-2024 — Abiomed, Inc. is recalling Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; (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, EU; Product Code: 0550-0002;
  type: MedicalDevice
  manufacturer: Abiomed, Inc.
claims: FDA recall Z-2961-2024: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
claims: FDA classified recall Z-2961-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2961-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2961-2024
      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: 0550-0002; UDI-DI: 00813502011630; Serial Numbers: 384019 384018 384017 384016 383757 383754 383756 383755 384616 384617 384613 384609 384594 384614 384615 384610 384611 384612 384709 384623 384622 384620 384619 384793 384792 384713 384712 384711 384790 384789 384888 384887 384886 384885 384791 384884 384813 384812 384810 384809 384838 384837 384836 384835 384871 384872 384834 384870 384869 397290 397289 393811 393812 393810 393809 397288 393808 397287 397286 395384 395383 394929 395382 395381 394926 394925 394928 394927 395380 398211 398210 398208 398566 398567 398207 400356 400355 400359 400358 400357 398569 400394 400392 400391 400390 403768 403662 403661 403659 403658 403483 403481 403482 403480 403771 403770 403264 397285 397282 397281 397284 397200 397199 397198 397197 397196 397130 397294 397295 397292 397293 397291 397499 397498 397496 397309 397310 397308 397307 397306 397500 397296 398570 397305 397304 397301 397303 397302 403265 403266 403769 404032 404031 404030 404028 403886 403885 403884 403880 403879 403878 403677 403676 403675 403674 403882 403111 403114 403113 403115 403201 403202 403204 403205 403222 403223 403807 403806 403803 403805 403540 403541 403565 403543 403568 403569 403804 404008 404009 404011 404010 404194 404195 404197 406441 406440 404012 404013 406439 406438 407859 407873 407872 407871 407858 407856 407870 407869 407868 407867 407866 407329 407328 407237 407086 407085 407084 407083 407082 407874 407236 407234 407232 407233 408571 408361 408362 408363 408364 408365 411257 411255 411254 408575 408574 408573 408572 411384 411382 411381 411390 411389 411388 411386 411385 411395 411394 411393 411392 411391 411444 411443 411442 411441 407327 411749 411748 411746 411747 411745 412014 412013 412012 412011 412010 407235 413093 413090 413089 413092 413091 412468 412469 412470 412471 412472 412361 412362 412363 412359 412360 412219 412220 412221 412222 412223 413641 413930 413644 413642 413931 413643 413640 413933 413932 413934 421…
      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-2961-2024: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
type: Claim
text: The FDA logged enforcement record Z-2961-2024: Abiomed, Inc. is voluntarily recalling Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; — 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: 0550-0002; UDI-DI: 00813502011630; Serial Numbers: 384019 384018 384017 384016 383757 383754 383756 383755 384616 384617 384613 384609 384594 384614 384615 384610 384611 384612 384709 384623 384622 384620 384619 384793 384792 384713 384712 384711 384790 384789 384888 384887 384886 384885 384791 384884 384813 384812 384810 384809 384838 384837 384836 384835 384871 384872 384834 384870 384869 397290 397289 393811 393812 393810 393809 397288 393808 397287 397286 395384 395383 394929 395382 395381 394926 394925 394928 394927 395380 398211 398210 398208 398566 398567 398207 400356 400355 400359 400358 400357 398569 400394 400392 400391 400390 403768 403662 403661 403659 403658 403483 403481 403482 403480 403771 403770 403264 397285 397282 397281 397284 397200 397199 397198 397197 397196 397130 397294 397295 397292 397293 397291 397499 397498 397496 397309 397310 397308 397307 397306 397500 397296 398570 397305 397304 397301 397303 397302 403265 403266 403769 404032 404031 404030 404028 403886 403885 403884 403880 403879 403878 403677 403676 403675 403674 403882 403111 403114 403113 403115 403201 403202 403204 403205 403222 403223 403807 403806 403803 403805 403540 403541 403565 403543 403568 403569 403804 404008 404009 404011 404010 404194 404195 404197 406441 406440 404012 404013 406439 406438 407859 407873 407872 407871 407858 407856 407870 407869 407868 407867 407866 407329 407328…
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-2961-2024 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.