CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,181 adverse event reports that list this exact device (DI 10607567108421), received between Aug 26, 2020 and Sep 30, 2026 — classified as 5 deaths, 6 injuries, 1,170 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (161 reports).

20 FDA recall records name this device's identifier, 20 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.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 ↗

4. 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 ↗

5. 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 ↗

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 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 ↗

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 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 ↗

16. 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 ↗

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 ↗

20. Mar 22, 2021Class IIIOpen, Classified

    There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

    Z-1506-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,181 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Connection Problem

  It was reported by the customer that during a routine check, before use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) ECG signal was found to be intermittent. There was no patient involvement and no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that upon inspection, it was found that the ECG cable connector had poor contact and needs to be replaced. The faulty ECG cable was retained by the hospital¿s equipment department.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944061 ↗
• MalfunctionSep 30, 2026Inability to Auto-Fill

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) alarmed Autofill Failure. No patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the PIM test could not be passed. Reinstalling the PIM component was ineffective. It was determined that the PIM was faulty. A PIM leak was discovered, and repeated tests failed. After replacing the PIM, the test returned to normal. The connected test balloon functioned correctly. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943412 ↗
• MalfunctionSep 29, 2026Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931249 ↗
• MalfunctionSep 28, 2026Gas/Air Leak

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a leak in the loop alarm. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that equipment alarmed and there was loop leak. Pneumatic Module was replaced. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912572 ↗
• MalfunctionSep 28, 2026Inability to Auto-Fill

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) failed to inflate automatically. No patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the safety disk had poor airtightness. After applying silicone grease, the issue was resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911320 ↗
• MalfunctionSep 28, 2026Battery Problem

  It was reported by the customer that during a routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) displayed an error message regarding the backup battery, indicating that the battery module could not be activated normally, which affected the device¿s emergency power supply function. No patient involved and no harm is reported. During a phone conversation it was determined that one of the batteries was faulty. Third-party company replaced the battery and confirmed that the device was functioning normally.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910933 ↗
• MalfunctionSep 24, 2026Failure to Sense

  It was reported by the customer, that during routine inspection, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) touchscreen had poor sensitivity. There was no patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE upon inspecting the equipment confirmed the touchscreen fault and fault code records. The FSE recalibrated the touchscreen. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881291 ↗
• MalfunctionSep 24, 2026Inability to Auto-Fill

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Autofill failure has been reported. No harm reported. When the machine malfunctioned, a new machine was installed, and the patients were not affected. The problem was found to be a malfunction in the inflation valve assembly. Field Service Engineer replaced the drive valve assembly; the machine system passed inspection and inflation was normal. The equipment passed all the inspections required by the factory. The equipment has been delivered to the customer and is ready for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880839 ↗
• MalfunctionSep 18, 2026Inability to Auto-Fill

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during the power-on test, the device displayed an Autofill failure. There was no patient involvement. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that on site inspection of the fault logs showed 0XF error. The problem was determined to be a fault in the solenoid valve control board. Solenoid valve control board was replaced. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815337 ↗
• MalfunctionSep 18, 2026Inability to Auto-Fill

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) failed to trigger automatic inflation. There was patient involvement. No harm was reported. The device was promptly replaced with another one. The Getinge FST was dispatched to evalaute the unit. The Pneumatic Interface Module (PIM) was determined to be faulty. After PIM replacement, the unit passed all functional and safety tests to manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815125 ↗
• MalfunctionSep 18, 2026Communication or Transmission Problem; Appropriate Device Problem Term/Code Not Available

  It was reported by the FSE that during a preventive maintenance the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a non-functional power switch. The device powers on after being plugged in. The machine was displaying an error code 139. There was no patient involved and no harm is reported. A Getinge FSE was dispatched to evaluate the unit. The FSE reported that after power management board was replaced the error was resolved. Moreover, it was reported that the problem remained and due to the shortage of spare parts it has not been resolved and the equipment was reported to be unusable. The equipment has been delivered to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814115 ↗
• MalfunctionSep 17, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Customer believes the unit is unstable and is not currently using the equipment. No patient involved. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800699 ↗
• MalfunctionSep 17, 2026Failure to Power Up

  It was reported by the customer that during a routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was unable to boot into the system. No patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE determined that the IABP valve assembly was defective. The customer postponed the repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798620 ↗
• MalfunctionSep 17, 2026No Apparent Adverse Event

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) blood pressure was too low. No patient involvement. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that all IABP tests were normal, and balloon inflation and deflation were normal. Product passed all functional and safety tests per manufacturer specifications. The device is ready for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797947 ↗
• MalfunctionSep 15, 2026Mechanical Problem; Failure to Power Up

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had an IABP fault requiring maintenance. There was no patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE found an electrical fault #14 upon startup. After replacing the motor, the test was normal. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770204 ↗
• MalfunctionSep 15, 2026Unexpected Shutdown

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. The machine shuts down unexpectedly and makes strange noises after being turned on for a while. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the video board is faulty and needs to be replaced. After replacing the motherboard, it passed the pre-use check and all machine functions and factory-set safety features were confirmed. The test results have been met and the device has been delivered for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770201 ↗
• MalfunctionSep 14, 2026Failure to Power Up

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) cannot be turned on. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that on-site inspection confirms the fault reported by the customer. The FSE replaced the Power management board. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751975 ↗
• MalfunctionSep 11, 2026Failure to Power Up

  It was reported that during pre-use inspection, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) power-on alarm electrical test 14. There was no information about patient involvement. No harm was reported. The customer replaced it with another device. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the equipment malfunctioned, displayed an error message upon startup, and could not start normally. After repair and testing, it was found to be working properly for customer use. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729893 ↗
• MalfunctionSep 11, 2026Erratic or Intermittent Display; Image Display Error/Artifact

  It was reported by the customer that, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) displayed a distorted screen after being turned on. There was no patient involvement. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that upon powering on the device, a screen flickering issue was discovered. After opening the back cover of the screen and reconnecting the video cable, the device returned to normal. Product passed all functional and safety tests per manufacturer specifications. It has been delivered to the user for use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729374 ↗
• MalfunctionSep 11, 2026Inability to Auto-Fill

  It was reported that during a routine inspection the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) alarmed an autofill. No patient involved and no harm is reported. The device is pending completion of repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728695 ↗
• MalfunctionSep 7, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50646025 ↗
• MalfunctionSep 2, 2026Inability to Auto-Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563319 ↗
• MalfunctionSep 1, 2026No Device Output; Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537847 ↗
• MalfunctionAug 31, 2026Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518751 ↗
• MalfunctionAug 31, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518405 ↗