CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,157 adverse event reports that list this exact device (DI 10607567108438), received between Aug 26, 2020 and Sep 30, 2026 — classified as 2 deaths, 1 injury, 1,154 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (157 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 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 ↗

6. 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 ↗

7. 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 ↗

8. 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 ↗

9. 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 ↗

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 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 ↗

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

    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 ↗

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 1,157 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Gas/Air Leak

  It was reported by the Field Service Engineer (FSE) that during service the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a helium leak and during tightening of a crew the bolt have sheared. No patient involved and no harm is reported. The FSE reported that the banjo bolt that connects helium line to external cylinder was replaced. Issue has been resolved. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942811 ↗
• MalfunctionSep 29, 2026Image Display Error/Artifact; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928426 ↗
• MalfunctionSep 28, 2026Communication or Transmission Problem; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  It was reported by the user that during procedure the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) shutdown, internal communication failed. Patient involved and no harm is reported. User swapped the unit for another. Field Service Engineer (FSE) arrived onsite and found fault code 115 in fault logs, software critical error, video gen board appear, exec board required to be replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911094 ↗
• MalfunctionSep 21, 2026Communication or Transmission Problem; Unexpected Shutdown

  It was reported that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) alarmed and stopped working. There is no information about patient involvement. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that critical error code 115 occurred. The FSE recommend to replace executive processor board.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837830 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component; Gas/Air Leak

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) failed a leak test. PIM leak test failed. 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 confirmed Patient Interface Module (PIM) test result failed. Machine physical overview reported OK. The FSE checked PIM and found IAB port was loose. Tightened it and performed PIM test and result passed. The FSE performed 30PSI calibration. Machine functional checks passed and safety test passed. Product passed all functional and safety tests per manufacturer specifications. Device was returned to user and cleared for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837171 ↗
• MalfunctionSep 21, 2026Fire; Failure to Power Up; Unexpected Shutdown

  It was reported by the customer that prior to use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was repeatedly switching off and on intermittently; electrical burning smell was detected from the unit. There was no patient involvement reported. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the issue. FSE found extensive internal electrical damage and all internal boards have blown. The device did not power on, displayed no lights or indications on the main board, and emitted a strong electrical burning smell. FSE was unable to get any information of the unit due to an internal burnout. The complaint involves electrical shutdown, possible fuse/wiring failure, and other electrical component damage.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835906 ↗
• MalfunctionSep 17, 2026Image Display Error/Artifact

  It was reported that during installation, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. There was no patient involvement reported. Display screen is found completely detached from the Touchscreen. Display screen was found with damage (lines on display). Display screen needs replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798311 ↗
• MalfunctionSep 17, 2026Mechanical Problem

  It was reported that during routine chekck by the customer CARDIOSAVE hybrid it was determined that upper bracket screen was faulty. There is no patient involved. No harm reported. The Getinge Field Service Technician was dispatched to evaluate the unit. It was reported that upper screen bracket was replaced. Following the replacement device passed all functional and safety tests according to factory specifications. Device was returned to customer and cleared for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798054 ↗
• MalfunctionSep 16, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784835 ↗
• MalfunctionSep 15, 2026Signal Artifact/Noise

  It was reported that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had an external ECG issue. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that when cardiosave is connected to the GE monitor to acquire external ECG, the response was slow and not accurate. New cable was replaced. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768833 ↗
• MalfunctionSep 15, 2026Signal Artifact/Noise

  It was reported that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had an external ECG issue. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that when cardiosave is connected to the GE monitor to acquire external ECG, the response was slow and not accurate. New cable was replaced. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768460 ↗
• MalfunctionSep 14, 2026Mechanical Problem

  It was reported by the FSE that during PM, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) compressor failed performance test. No patient involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that compressor failed to reach pressure setpoint. New compressor fitted which solved the problem and it can now calibrate the pressure setpoint. Completed repair successfully. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751656 ↗
• MalfunctionSep 14, 2026Calibration Problem

  It was reported the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) failed Touchscreen calibration test. No patient involved and no harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749500 ↗
• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings; Gas/Air Leak

  It was reported by the customer that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is leaking helium gas. No patient involved. No harm was reported. The FSE was dispatched to evaluate the unit. It was reported that screen showing helium is empty. FSE couldnt get screen to show an empty bottle. Full bottle on machine and half bottle also on site. FSE tried both bottles and both showing to have gas on analog display and digital. There was a slight leak when unit was in the cart, maybe down to o-ring. Replaced this o-ring and completed leak checks. All within manual specifications. Functional tests done and seen to pass. Completed repair successfully. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731296 ↗
• MalfunctionSep 11, 2026Power Problem

  It was reported that prior to use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) electrical safety test failed. No patient involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that new cable reel were ordered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727437 ↗
• MalfunctionSep 10, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713295 ↗
• MalfunctionSep 10, 2026Charging Problem

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) does not charge up at all. There was no patient involvement. No harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707306 ↗
• MalfunctionSep 3, 2026Failure to Power Up; Gas/Air Leak

  It was reported by the customer that during installation, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) failed All Manifold Checks on PIM test. 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 PIM needs replacement. After PIM was replaced, the original fault was resolved but device failed electrical safety test.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50582832 ↗
• MalfunctionSep 1, 2026Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540163 ↗
• MalfunctionSep 1, 2026Inability to Auto-Fill; Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537399 ↗
• MalfunctionAug 30, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50514674 ↗
• MalfunctionAug 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50494568 ↗
• MalfunctionAug 28, 2026Image Display Error/Artifact

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50494255 ↗
• MalfunctionAug 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492713 ↗
• MalfunctionAug 23, 2026Display Difficult to Read; Charging Problem

  It was reported by the customer that during clinical use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) battery was unable to charge and had a not clear Display. Display screen has glitch (red color) on waveform display. Patient was involved. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that bay2 slot cannot perform battery charging process. Power management board was re-seated and issue remain same. Full charged battery was returned back. Power management board was replaced the next day and Bay2 was able to charge battery. Restarted machine 3 times and display working OK, no glitch issue happened on display screen. Performed display test and result passed. Performed machine simulation for 2 hours and display screen working OK. End user has to monitor the issue for four weeks. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50393952 ↗