Pump 371 14F LT CMR Set; Product Code: 0048-0045;
type: Dataset
description: FDA recall Z-2959-2024 — Abiomed, Inc. is recalling Pump 371 14F LT CMR Set; Product Code: 0048-0045; (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: Pump 371 14F LT CMR Set; Product Code: 0048-0045;
  type: MedicalDevice
  manufacturer: Abiomed, Inc.
claims: FDA recall Z-2959-2024: Abiomed, Inc. is recalling Pump 371 14F LT CMR Set; Product Code: 0048-0045;
claims: FDA classified recall Z-2959-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2959-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2959-2024
      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: 0048-0045; UDI-DI: 00813502011876; Serial Numbers: 381707 379142 384464 378824 378853 383418 384433 382733 384889 382279 384890 382280 384814 382281 384815 382282 382283 384816 384817 382284 384624 384625 382286 384818 384819 384820 384821 384822 384823 383689 382734 382735 383684 382736 382737 383686 382738 382739 383687 382740 383688 382741 383744 382742 383745 383520 383746 383521 383747 383522 383748 383749 383750 383751 383752 383753 383523 384891 383524 384892 382287 383525 383526 384893 381601 383527 381602 384894 383529 381604 384895 381605 384896 381606 381607 384897 381608 384898 381609 383798 381610 383799 383801 381325 383800 383802 381326 383803 381327 381566 381567 381568 381569 381571 381572 381573 381574 381575 383017 383291 383292 383293 383294 383295 383296 383297 383298 383299 383300 383251 383254 383256 383257 383258 383260 383261 383262 383264 383266 383267 383268 383269 383690 383691 383692 383693 383026 383241 383244 383245 383247 383248 383249 383250 382395 383252 383253 384954 384953 384952 384951 384950 384949 383019 383020 383021 383022 383023 383024 383025 384579 384580 383242 384581 383243 384582 384583 383246 384585 384586 384587 384588 384959 384899 384900 384901 384903 384904 384960 384907 384961 384962 384963 384964 384965 384966 384967 384968 384363 384364 384365 384366 384367 384368 384955 384956 384957 384958 383828 384171 383829 384172 384173 384174 384175 375965 384176 375967 375968 384177 375969 375970 384178 375971 384179 384180 384211 384212 384213 384214 384215 384217 384218 384219 384220 384231 384232 384233 384234 384235 375973 384236 384237 383945 375974 383946 383942 383948 383941 383950 380075 374496 384141 384143 384144 384145 384146 384147 384148 384149 384150 383824 383825 383827 383830 375576A 381545 375966 375972 383944 380589 380590 380592 380586 380588 380584 380585 380076 380079 380080 380081 380082 380083 380084 380320 380321 380322 380323 380324 380325 380326 380327 380329 380909 380910 380911 38…
      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-2959-2024: Abiomed, Inc. is recalling Pump 371 14F LT CMR Set; Product Code: 0048-0045;
type: Claim
text: The FDA logged enforcement record Z-2959-2024: Abiomed, Inc. is voluntarily recalling Pump 371 14F LT CMR Set; Product Code: 0048-0045; — 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: 0048-0045; UDI-DI: 00813502011876; Serial Numbers: 381707 379142 384464 378824 378853 383418 384433 382733 384889 382279 384890 382280 384814 382281 384815 382282 382283 384816 384817 382284 384624 384625 382286 384818 384819 384820 384821 384822 384823 383689 382734 382735 383684 382736 382737 383686 382738 382739 383687 382740 383688 382741 383744 382742 383745 383520 383746 383521 383747 383522 383748 383749 383750 383751 383752 383753 383523 384891 383524 384892 382287 383525 383526 384893 381601 383527 381602 384894 383529 381604 384895 381605 384896 381606 381607 384897 381608 384898 381609 383798 381610 383799 383801 381325 383800 383802 381326 383803 381327 381566 381567 381568 381569 381571 381572 381573 381574 381575 383017 383291 383292 383293 383294 383295 383296 383297 383298 383299 383300 383251 383254 383256 383257 383258 383260 383261 383262 383264 383266 383267 383268 383269 383690 383691 383692 383693 383026 383241 383244 383245 383247 383248 383249 383250 382395 383252 383253 384954 384953 384952 384951 384950 384949 383019 383020 383021 383022 383023 383024 383025 384579 384580 383242 384581 383243 384582 384583 383246 384585 384586 384587 384588 384959 384899 384900 384901 384903 384904 384960 384907 384961 384962 384963 384964 384965 384966 384967 384968 384363 384364 384365 384366 384367 384368 384955 384956 384957 384958 383828 384171 383829 384172 384173 384174 38417…
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-2959-2024 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.