CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,686 adverse event reports that list this exact device (DI 10607567108414), received between Aug 3, 2020 and Sep 30, 2026 — classified as 8 deaths, 2 injuries, 1,675 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (212 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.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 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 ↗

6. 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 ↗

7. 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 ↗

8. 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 ↗

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

    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 ↗

11. 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 ↗

12. May 4, 2023Class IIIOpen, Classified

    The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

    Z-1907-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. 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 ↗

14. 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 ↗

15. 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 ↗

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. 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 ↗

18. 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 ↗

19. 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 ↗

20. 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 1,686 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Battery Problem

  It was reported by customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. No patient involved, no harm reported. Monitor displays battery warning has been reported. IABP slot two does not charge any battery even if Field Service Engineer put the battery from slot 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944918 ↗
• MalfunctionSep 30, 2026Charging Problem

  It was reported by customer that prior to use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a problem with charging batteries. There was no patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE ran a battery discharge test and and tested the device using a test baloon. The battery reportedly charges normally. Device is operational and complies with the manufacturer¿s specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944359 ↗
• MalfunctionSep 30, 2026Failure to Power Up

  It was reported by the customer that during a routine check before use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had Fault #14 (Power-Up Test Fails # 14 (Prior Compressor Failure ETF)). There was no patient involvement, no harm was reported. A Getinge Field Service Engineer (FSE) reported that the compressor is planned to be replaced, the error code directly indicates a compressor fault.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943595 ↗
• MalfunctionSep 30, 2026Unexpected Shutdown

  It was reported by the customer that during a routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had an unexpected shutdown. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942457 ↗
• MalfunctionSep 30, 2026Device Contamination with Body Fluid

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) experienced a blood back event. Patient was involved and no harm was reported.The device did not shutdown due to blood back. FSE was dispatched to evaluate the unit. It was established that blood had entered the device as a result of the user employing a non-original ¿Balton¿ brand catheter and connecting it incorrectly; consequently, the Pneumatic Interface Module, Cartridge Filter and Assembly, and Safety Disk components failed due to blood ingress. The faulty components must be replaced with new ones.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942214 ↗
• MalfunctionSep 29, 2026Battery Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931132 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) Helium cylinder was not detected by the device. 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 calibration of helium transducers, low and high pressure, was performed. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930590 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930094 ↗
• MalfunctionSep 29, 2026No Device Output; Application Network Problem

  It was reported by Getinge Field Service Engineer (FSE) that during product training, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Device freeze, was unable to switch between pressure to ECG trigger. No patient involved. No harm reported. Device was unable to trigger alarms. After disconnecting IAB from the pump, Cardiosave continued pumping without an alarm. After restart device worked as expected. Pump was reported to be updated to D.03 software the day before.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930089 ↗
• MalfunctionSep 28, 2026Battery Problem; Insufficient Device Problem Information

  It was reported that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had fault A4. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the error is not reproducible. The system simply requested battery maintenance tests via a message. Once the tests were performed, the message stopped appearing. Maintenance was performed on batteries. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911233 ↗
• MalfunctionSep 22, 2026Leak/Splash; Gas/Air Leak

  It was reported by the customer that prior to use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a Gas leak. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched on site and checked the device. Multiple Gas Loss in IAB Circuit alarm were present in logs. The FSE found no malfunction with the unit. Error could not be duplicated. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853306 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem; Leak/Splash; Pumping Problem

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) stopped working, and the screen was frozen. There was no information about patient involvement, no harm reported. After restarting by the customer, unit worked again. According to the information provided by the customer there are traces of saline visible.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852782 ↗
• MalfunctionSep 21, 2026Failure to Power Up; Failure to Calibrate

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) displayed error code 6 upon startup. There was no patient involvement reported. No harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE replaced the defective touchscreen assembly and calibrated the unit. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836187 ↗
• MalfunctionSep 18, 2026Unexpected Shutdown

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) shut down. No patient involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that a review of the system logs found no anomalies, alerts, or prior error codes that would account for the reported shutdown. The device underwent inspection and functional testing, including battery charging/discharging verification, battery operation checks, error review, and confirmation of the most recent battery maintenance ((b)(6)2026). All tests were successfully completed, the device remained operational during testing with no shutdowns observed, and no issues were identified. The equipment is functioning correctly and is suitable for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816592 ↗
• MalfunctionSep 18, 2026Power Problem

  It was reported by the customer that during the routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) does not have an AC cord reel. There was no patient involved. No harm was reported. Field Service Engineer (FSE) received a report that the Cardiosave device cant retract the AC cord. Upon inspection, the AC power cord set was found to be damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814865 ↗
• MalfunctionSep 18, 2026Fire

  It was reported by the customer that during using for teaching and learning, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a burning smell. There was no patient involvement. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that upon inspection, burn marks were found on the electronic components of the Exec. Processor Board, and soot was found on the Front End Board. Parts will be replaced and installed later.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814189 ↗
• MalfunctionSep 17, 2026Inflation Problem; Failure to Power Up

  It was reported by the user that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) did not inflate balloon. 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 unit had power up test fail# 15. PIM was disassembled and checked. Unit was calibrated. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50799891 ↗
• MalfunctionSep 17, 2026Mechanical Problem; Material Integrity Problem

  It was reported by the user support team that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) alarmed IABP May Required Maintenance Message. There was no patient involvement. No harm is reported. After initial inspection Drive Regulator Calibration failed, it is suspected that the issue may be related to the compressor scroll.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50799716 ↗
• MalfunctionSep 16, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785811 ↗
• MalfunctionSep 15, 2026Gas/Air Leak

  It was reported by user support department that during clinical use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) alarmed gas loss. Patient involved. No harm reported. The issue discovered by the customer. The Getinge Field Service AEngineer (FSE) was dispatched to evaluate the unit. Upon checking it and connecting to test ballon no Gas Loss in IAB Circuit was found and device was found to be functioning normally. All functional and safety checks have been performed to factory specifications and the unit has been returned to use. Pump was exchanged to continue treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768667 ↗
• MalfunctionSep 14, 2026Failure to Read Input Signal

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) stopped showing the ECG. The hospital switched the patient to another pump to continue therapy. No harm was reported. A Getinge Field Service Engineer (FSE) arrived onsite and found that ECG cable is damaged. FSE replaced: Cable Assembly, ECG Leadwire Set, Operat and Cable Assembly, ECG Trunk Cable, 5-lead. Product passed all functional and safety tests per manufacturer specifications. The replaced components are being returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752627 ↗
• MalfunctionSep 11, 2026Inability to Auto-Fill; Disconnection

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) displayed a message - Filling Error. 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 alarm logs confirmed the occurrence of filling errors - Autofill Failure and IAB disconnect. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730569 ↗
• MalfunctionSep 10, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50709046 ↗
• MalfunctionSep 8, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50666038 ↗
• MalfunctionSep 7, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50646240 ↗