CARDIOSAVE HYBRID TYPE D PLUG 0998-00-0800-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 10607567109008), received between Aug 27, 2021 and Sep 28, 2026 — classified as 2 deaths, 228 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (36 reports).

19 FDA recall records name this device's identifier, 19 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 4, 2025Class IIOpen, Classified

   The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

   Z-0916-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

2. Oct 23, 2025Class IIIOpen, Classified

   The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

   Z-0931-2026 · Root cause: Process change control · Recall details · FDA record ↗

3. Aug 8, 2024Class IOpen, Classified

   Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

   Z-3134-2024 · Root cause: Software design · Recall details · FDA record ↗

4. Aug 8, 2024Class IOpen, Classified

   Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

   Z-3136-2024 · Root cause: Software design · Recall details · FDA record ↗

5. Jul 31, 2023Class IOpen, Classified

   Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

   Z-2431-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Jul 31, 2023Class IOpen, Classified

   Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.

   Z-2435-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Jul 31, 2023Class IOpen, Classified

   Users were identifying autofill failure conditions on the devices causing pump stops.

   Z-2437-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jul 31, 2023Class IIOpen, Classified

   Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

   Z-2486-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Jul 31, 2023Class IOpen, Classified

   Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

   Z-2433-2023 · Root cause: Device Design · Recall details · FDA record ↗

10. Jun 5, 2023Class IOpen, Classified

    IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.

    Z-2149-2023 · Root cause: Device Design · Recall details · FDA record ↗

11. Jun 5, 2023Class IOpen, Classified

    An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

    Z-2151-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

12. Feb 28, 2023Class IIOpen, Classified

    There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.

    Z-1276-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. Feb 7, 2023Class IIOpen, Classified

    There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.

    Z-1229-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Feb 7, 2023Class IOpen, Classified

    An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.

    Z-1145-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. Feb 7, 2023Class IOpen, Classified

    An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.

    Z-1147-2023 · Root cause: Software design · Recall details · FDA record ↗

16. Feb 7, 2023Class IIOpen, Classified

    Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

    Z-1231-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗

17. Dec 19, 2022Class IOpen, Classified

    The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.

    Z-0885-2023 · Root cause: Device Design · Recall details · FDA record ↗

18. Nov 15, 2021Class IOpen, Classified

    Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

    Z-0336-2022 · Root cause: Device Design · Recall details · FDA record ↗

19. Sep 21, 2021Class IOpen, Classified

    A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

    Z-0091-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Power Problem

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was not turning on. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed the reported issue, checked power connections and identified issue in Power Management Board. Part requires replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913636 ↗
• MalfunctionSep 28, 2026Communication or Transmission Problem

  It was reported that during a routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is showing the error message "Internal Communication Failure". No patient was involved. No harm was reported. A Getinge Field Service Engineer was dispatched to evaluate the unit. The FSE reset the connections for supply board in the cart, connections for power management, solenoid driver and all other electronics. The IABP was ran on test balloon for 24 hours, no issue was observed. Inspection is complete. The unit passed all functional and safety tests to manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913425 ↗
• MalfunctionSep 28, 2026Circuit Failure; Failure to Power Up

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is not booting up. There was no patient involved. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that they checked the device, observed the mentioned issue and after resetting the connections of all circuit boards and connectors the machine displayed Fault Code F0 on the Executive processor Board. Problem was still persisted. FSE visited the site and checked the machine with mentioned testing spare parts. Required Spare Part: Executive Processor Board.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911782 ↗
• MalfunctionSep 25, 2026Failure to Power Up

  It was reported by the Field Service Technician, that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Unit not getting on has been reported. No patient involved. No harm reported. The Equipment was used on AC Power and Batteries. FSE arrived on site and check the machine, found machine power ON normally without and error power input and basic functionally checked. Multiple power ON/Off cycles were performed and the Cardosave machine operated normally after then perform the drive manifold test and PIM test, all test passed, machine handed over to user in good working condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894448 ↗
• MalfunctionSep 24, 2026Erratic or Intermittent Display

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) display was flickering. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed that the display is flickering intermittently and found the problem in the display to receiver board cable. After replacing the cable, the problem has been solved. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878897 ↗
• MalfunctionSep 23, 2026Power Problem

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was not switching on mains supply. There was no patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that power cord gone defective and needs to be replaced. After replacing the AC power cord, the problem was solved. All functional and safety checks have been performed to factory specifications, and the unit has been returned to use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866829 ↗
• MalfunctionSep 23, 2026Obstruction of Flow

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was displaying an alarm "IAB catheter restriction". There was no patient involved. No harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that all manifold tests are done, deep vacuum test is failing in drive manifold test, also the vacuum setpoint value is out of range, the vacuum regulator muffler is faulty. Replacement part has been ordered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866084 ↗
• MalfunctionSep 22, 2026Failure to Power Up

  It was reported by the customer's FSE that, during a routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) failed to power on. There was no patient involvement, and no harm or adverse event was reported. A Getinge FSE was dispatched to evaluate the unit. The FSE reported that chcecked the machine switch on. Machine display is getting ON. Performed the PIM and Drive Manifold test. The machine is in good working condition. Handed over to user. All required functional and safety checks were performed as per factory specifications, and the unit was returned to use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850571 ↗
• MalfunctionSep 18, 2026Calibration Problem

  It was reported that during routine check by customer, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) unit had the message "IABP may require maintenance". There was no patient involvement and no harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the vacuum regulator was out of range, and performed calibration. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813784 ↗
• MalfunctionSep 16, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784879 ↗
• MalfunctionSep 15, 2026Power Problem

  It was reported that during routine check by the customer the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. The Mains Indication light not glowing. No patient involved. There was no patient harm reported. The Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. It was reported that main power indication assembly need to be replaced. No fault logs available. FSE stated that Power Cord and AC mains is working correctly and that only light is not working properly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767912 ↗
• MalfunctionSep 10, 2026Charging Problem; Power Problem

  It was reported by the FSE that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is not showing main supply. There was no patient involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the machine was checked and no mains voltages were detected on the power cord or power supply. Unit is not showing the mains supply indicator and not charging the batteries as well. FSE found that below mentioned spare are defective. Replaced the same and resolved the issue.Device passed the all safety and functional checks successfully. Device was returned to customer and cleared for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50708896 ↗
• MalfunctionSep 8, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50663559 ↗
• MalfunctionAug 31, 2026Inability to Auto-Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515866 ↗
• MalfunctionAug 31, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515717 ↗
• MalfunctionAug 30, 2026Inability to Auto-Fill; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50513153 ↗
• MalfunctionAug 28, 2026Failure to Power Up

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was not switching on. No patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. FSE confirmed that the device did not power on and emitted beep sound. Found problem with Display Monitor to Video Generator Board Kit which have been replaced. All functional tests were performed and all calibrations were verified. Required calibration of Vacuum and Pressure Regulators was done. Unit was tested with System trainer with balloon pumping and found working in satisfactory condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492021 ↗
• MalfunctionAug 23, 2026Failure to Power Up

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50394417 ↗
• MalfunctionAug 8, 2026Failure to Power Up; Battery Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50185488 ↗
• MalfunctionAug 7, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50172177 ↗
• MalfunctionJul 28, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50051810 ↗
• MalfunctionJul 27, 2026Failure to Power Up

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017575 ↗
• MalfunctionMay 12, 2026Inability to Auto-Fill

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) MALFUNCTIONED. THE UNIT SHOWS AUTOFILL FAILURE ERROR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150817 ↗
• MalfunctionMay 6, 2026Failure to Zero

  IT WAS REPORTED BEFORE USE THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) DISPLAYED PRESSURE ZEROING ISSUE. THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094155 ↗
• MalfunctionMay 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A ROUTINE CHECKUP, THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD A CATHETER RESTRICTION ERROR. NO PATIENTS WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25079421 ↗