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  "name": "Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.   (1) Product Code 005042 - Impella 2.5   (2) Product Code 005062 - Impella 5.0   (3) Product Code 005082- Impella LD   (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist   (8) Product Code 0048-0032 - Impella CP   (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist    ***Updated February 2024***   (10) 004413 - Impella 2.5 Set   (12) 0046-0026 - Impella 5.0 Pump Set ROW   (13) 0046-0037 - Impella 5.0 Pump Set APAC   (15) 004680-AU - 5.0 Pump Set AU   (16) 0048-0002 - Impella CP Pump Set, EU   (17) 0048-0002-BR - Impella CP Pump Set BR   (18) 0048-0004 - Impella CP Pump Set, Canada   (19) 0048-0014 - Impella CP Smart Assist Set, EU   (20) 0048-0024-JP - Impella CP Smart Assist Set, JP   (21) 0048-0044 - Impella CP Smart Assist Set, Canada   (22) 0048-0047 - Impella CP Smart Assist Set APAC   (23) 005040 - Impella 2.5 IMC Pump Set EU   (24) 005048-JP - Impella 2.5 Pump Set, Japan   (25) 005060 - Impella 5.0 IMC Pump Set EU   (26) 005064 - Impella 5.0 IMC Pump Set Canada   (27) 005066-JP - Impella 5.0 Pump Set, Japan   (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU   (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA   (30) 1000115 - Impella CP Pump set, APAC   (31) 1000211 - Impella 5.5 SmartAssist Set, JP   (32) 1000302 - Impella CP with SmartAssist APAC   (33) 1000361 - Impella 5.5 Set AU   (34) 1000402 - Impella CP Smart Assist Set   ***Updated March 15, 2024***   The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation:   (4) Product Code 004334 - Impella RP   (5) Product Code 0046-0035 - Impella RP with SmartAssist   (6) Product Code 1000323 - RP Flex with SmartAssist   (11) 0046-0011 - Impella RP Pump Set, EU   (14) 0046-0039 - Impella RP Set APAC",
  "description": "FDA recall Z-0980-2024 — Abiomed, Inc. is recalling Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.   (1) Product Code 005042 - Impella 2.5   (2) Product Code 005062 - Impella 5.0   (3) Product Code 005082- Impella LD   (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist   (8) Product Code 0048-0032 - Impella CP   (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist    ***Updated February 2024***   (10) 004413 - Impella 2.5 Set   (12) 0046-0026 - Impella 5.0 Pump Set ROW   (13) 0046-0037 - Impella 5.0 Pump Set APAC   (15) 004680-AU - 5.0 Pump Set AU   (16) 0048-0002 - Impella CP Pump Set, EU   (17) 0048-0002-BR - Impella CP Pump Set BR   (18) 0048-0004 - Impella CP Pump Set, Canada   (19) 0048-0014 - Impella CP Smart Assist Set, EU   (20) 0048-0024-JP - Impella CP Smart Assist Set, JP   (21) 0048-0044 - Impella CP Smart Assist Set, Canada   (22) 0048-0047 - Impella CP Smart Assist Set APAC   (23) 005040 - Impella 2.5 IMC Pump Set EU   (24) 005048-JP - Impella 2.5 Pump Set, Japan   (25) 005060 - Impella 5.0 IMC Pump Set EU   (26) 005064 - Impella 5.0 IMC Pump Set Canada   (27) 005066-JP - Impella 5.0 Pump Set, Japan   (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU   (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA   (30) 1000115 - Impella CP Pump set, APAC   (31) 1000211 - Impella 5.5 SmartAssist Set, JP   (32) 1000302 - Impella CP with SmartAssist APAC   (33) 1000361 - Impella 5.5 Set AU   (34) 1000402 - Impella CP Smart Assist Set   ***Updated March 15, 2024***   The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation:   (4) Product Code 004334 - Impella RP   (5) Product Code 0046-0035 - Impella RP with SmartAssist   (6) Product Code 1000323 - RP Flex with SmartAssist   (11) 0046-0011 - Impella RP Pump Set, EU   (14) 0046-0039 - Impella RP Set APAC (Devices, Class I). 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.",
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    "name": "Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.   (1) Product Code 005042 - Impella 2.5   (2) Product Code 005062 - Impella 5.0   (3) Product Code 005082- Impella LD   (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist   (8) Product Code 0048-0032 - Impella CP   (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist    ***Updated February 2024***   (10) 004413 - Impella 2.5 Set   (12) 0046-0026 - Impella 5.0 Pump Set ROW   (13) 0046-0037 - Impella 5.0 Pump Set APAC   (15) 004680-AU - 5.0 Pump Set AU   (16) 0048-0002 - Impella CP Pump Set, EU   (17) 0048-0002-BR - Impella CP Pump Set BR   (18) 0048-0004 - Impella CP Pump Set, Canada   (19) 0048-0014 - Impella CP Smart Assist Set, EU   (20) 0048-0024-JP - Impella CP Smart Assist Set, JP   (21) 0048-0044 - Impella CP Smart Assist Set, Canada   (22) 0048-0047 - Impella CP Smart Assist Set APAC   (23) 005040 - Impella 2.5 IMC Pump Set EU   (24) 005048-JP - Impella 2.5 Pump Set, Japan   (25) 005060 - Impella 5.0 IMC Pump Set EU   (26) 005064 - Impella 5.0 IMC Pump Set Canada   (27) 005066-JP - Impella 5.0 Pump Set, Japan   (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU   (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA   (30) 1000115 - Impella CP Pump set, APAC   (31) 1000211 - Impella 5.5 SmartAssist Set, JP   (32) 1000302 - Impella CP with SmartAssist APAC   (33) 1000361 - Impella 5.5 Set AU   (34) 1000402 - Impella CP Smart Assist Set   ***Updated March 15, 2024***   The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation:   (4) Product Code 004334 - Impella RP   (5) Product Code 0046-0035 - Impella RP with SmartAssist   (6) Product Code 1000323 - RP Flex with SmartAssist   (11) 0046-0011 - Impella RP Pump Set, EU   (14) 0046-0039 - Impella RP Set APAC",
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      "name": "FDA recall Z-0980-2024: Abiomed, Inc. is recalling Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.   (1) Product Code 005042 - Impella 2.5   (2) Product Code 005062 - Impella 5.0   (3) Product Code 005082- Impella LD   (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist   (8) Product Code 0048-0032 - Impella CP   (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist    ***Updated February 2024***   (10) 004413 - Impella 2.5 Set   (12) 0046-0026 - Impella 5.0 Pump Set ROW   (13) 0046-0037 - Impella 5.0 Pump Set APAC   (15) 004680-AU - 5.0 Pump Set AU   (16) 0048-0002 - Impella CP Pump Set, EU   (17) 0048-0002-BR - Impella CP Pump Set BR   (18) 0048-0004 - Impella CP Pump Set, Canada   (19) 0048-0014 - Impella CP Smart Assist Set, EU   (20) 0048-0024-JP - Impella CP Smart Assist Set, JP   (21) 0048-0044 - Impella CP Smart Assist Set, Canada   (22) 0048-0047 - Impella CP Smart Assist Set APAC   (23) 005040 - Impella 2.5 IMC Pump Set EU   (24) 005048-JP - Impella 2.5 Pump Set, Japan   (25) 005060 - Impella 5.0 IMC Pump Set EU   (26) 005064 - Impella 5.0 IMC Pump Set Canada   (27) 005066-JP - Impella 5.0 Pump Set, Japan   (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU   (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA   (30) 1000115 - Impella CP Pump set, APAC   (31) 1000211 - Impella 5.5 SmartAssist Set, JP   (32) 1000302 - Impella CP with SmartAssist APAC   (33) 1000361 - Impella 5.5 Set AU   (34) 1000402 - Impella CP Smart Assist Set   ***Updated March 15, 2024***   The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation:   (4) Product Code 004334 - Impella RP   (5) Product Code 0046-0035 - Impella RP with SmartAssist   (6) Product Code 1000323 - RP Flex with SmartAssist   (11) 0046-0011 - Impella RP Pump Set, EU   (14) 0046-0039 - Impella RP Set APAC",
      "text": "The FDA logged enforcement record Z-0980-2024: Abiomed, Inc. is voluntarily recalling Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.   (1) Product Code 005042 - Impella 2.5   (2) Product Code 005062 - Impella 5.0   (3) Product Code 005082- Impella LD   (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist   (8) Product Code 0048-0032 - Impella CP   (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist    ***Updated February 2024***   (10) 004413 - Impella 2.5 Set   (12) 0046-0026 - Impella 5.0 Pump Set ROW   (13) 0046-0037 - Impella 5.0 Pump Set APAC   (15) 004680-AU - 5.0 Pump Set AU   (16) 0048-0002 - Impella CP Pump Set, EU   (17) 0048-0002-BR - Impella CP Pump Set BR   (18) 0048-0004 - Impella CP Pump Set, Canada   (19) 0048-0014 - Impella CP Smart Assist Set, EU   (20) 0048-0024-JP - Impella CP Smart Assist Set, JP   (21) 0048-0044 - Impella CP Smart Assist Set, Canada   (22) 0048-0047 - Impella CP Smart Assist Set APAC   (23) 005040 - Impella 2.5 IMC Pump Set EU   (24) 005048-JP - Impella 2.5 Pump Set, Japan   (25) 005060 - Impella 5.0 IMC Pump Set EU   (26) 005064 - Impella 5.0 IMC Pump Set Canada   (27) 005066-JP - Impella 5.0 Pump Set, Japan   (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU   (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA   (30) 1000115 - Impella CP Pump set, APAC   (31) 1000211 - Impella 5.5 SmartAssist Set, JP   (32) 1000302 - Impella CP with SmartAssist APAC   (33) 1000361 - Impella 5.5 Set AU   (34) 1000402 - Impella CP Smart Assist Set   ***Updated March 15, 2024***   The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation:   (4) Product Code 004334 - Impella RP   (5) Product Code 0046-0035 - Impella RP with SmartAssist   (6) Product Code 1000323 - RP Flex with SmartAssist   (11) 0046-0011 - Impella RP Pump Set, EU   (14) 0046-0039 - Impella RP Set APAC — reason: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-27. Affected lots/codes: UDI-DI   (1) 00813502011081   (2) 00813502011180   (3) 00813502011227   (7) 00813502011531 and 00813502012828   (8) 00813502011388   (9) 00813502012279 and 00813502011876   All product IFUs include the Update   ***Added February 2024***   (10) 813502010947   (12) 813502011821   (13) 813502011937   (15) N/A   (16) 4260113630242   (17) 813502011777   (18) 813502011265   (19) 4260113630280   (20) 813502011609   (21) 813502012200   (22) 813502011944   (23) 4260113630136   (24) 813502010046   (25) 4260113630174   (26) 813502011197   (27) 813502010053   (28) 813502011630   (29) 813502010466   (30) 813502010473   (31) 813502012453   (32) 813502012767   (33) 813502012873   (34) 813502012873     ***Removed from scope March 15, 2024***   (4) 00813502011029   (5) 00813502011869   (6) 00813502012811   (11) 4260113630273   (14) 813502011951. A RECORDED FDA enforcement action (occurred=true).",
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      "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."
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      "name": "FDA classified recall Z-0980-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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.",
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        "value": "Class I",
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      "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."
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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."
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Value": "Abiomed, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.",
            "Status": "recorded"
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2023-12-27",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI   (1) 00813502011081   (2) 00813502011180   (3) 00813502011227   (7) 00813502011531 and 00813502012828   (8) 00813502011388   (9) 00813502012279 and 00813502011876   All product IFUs include the Update   ***Added February 2024***   (10) 813502010947   (12) 813502011821   (13) 813502011937   (15) N/A   (16) 4260113630242   (17) 813502011777   (18) 813502011265   (19) 4260113630280   (20) 813502011609   (21) 813502012200   (22) 813502011944   (23) 4260113630136   (24) 813502010046   (25) 4260113630174   (26) 813502011197   (27) 813502010053   (28) 813502011630   (29) 813502010466   (30) 813502010473   (31) 813502012453   (32) 813502012767   (33) 813502012873   (34) 813502012873     ***Removed from scope March 15, 2024***   (4) 00813502011029   (5) 00813502011869   (6) 00813502012811   (11) 4260113630273   (14) 813502011951",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.",
            "Status": "recorded"
          }
        }
      ]
    }
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}