The Recall Desk

Hazard

Hemodynamic Instability recalls

9 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9
Critical
1
Severe
7
Most recent
2024-10-02

Of the 9 hemodynamic instability recalls we have scored against our rubric, 1 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (78%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all hemodynamic instability recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–9 of 9

  • SevereFDA (Devices)·Z-3135-2024·2024-10-02

    CARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk

    Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3134-2024·2024-10-02

    Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk

    Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.

    Product
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3137-2024·2024-10-02

    CARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability

    Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3136-2024·2024-10-02

    Cardiac Support Device Software Defect Risks Hemodynamic Instability

    Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.

    Product
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0123-2024·2023-11-01

    B. Braun Infusomat Large Volume Pump may stop delivering medication due to false alarm

    The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.

    Product
    8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0124-2024·2023-11-01

    Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication

    B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.

    Product
    8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1148-2023·2023-03-15

    Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly

    The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.

    Product
    Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2022·2021-12-22

    Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

    Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

    Product
    Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2022·2021-12-22

    FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress

    Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.

    Product
    Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide