CARDIOSAVE HYBRID TYPE I (AU) 0998-00-0800-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 10607567109053), received between Sep 21, 2020 and Sep 29, 2026 — classified as 6 injuries, 226 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (28 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 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 ↗

7. 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 ↗

8. 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 ↗

9. 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 ↗

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

• MalfunctionSep 29, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928721 ↗
• MalfunctionSep 29, 2026Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928276 ↗
• MalfunctionSep 17, 2026Moisture or Humidity Problem

  It was reported that, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a condensation error. There was no information about patient involvement. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798464 ↗
• MalfunctionSep 15, 2026Image Display Error/Artifact

  It was reported that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) display screen is red. It is unknown when the malfunction occurred. There was no information about patient involvement. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767066 ↗
• MalfunctionSep 9, 2026Failure to Power Up

  It was reported by the customer that during standby, while charging, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was not turning on. There was no patient involvement. No harm was reported. An issue was identified with the 9V battery - it has corroded onto the Alarm Daughter Board. Alarm Daughter Board and Alarm Board to Exec Processor Cable have been ordered for replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684197 ↗
• MalfunctionAug 28, 2026Gas/Air Leak

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492712 ↗
• MalfunctionAug 27, 2026Leak/Splash

  It was reported by the customer that during use on patient the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was having gas loss leak alarm, causing IABP to stop. No harm was reported. Intra-Aortic Balloon (IAB) fill was done by pressing IAB refill and started again, issue then repeated. A Getinge Filed Service Engineer (FSE) was dispatched to evaluate the unit. FSE confirmed gas loss alarms in logs. No other errors were noted. All Manifold Test were successfully performed, no leak detected on device. FSE ran device in clinical mode - unable to replicate gas loss alarm, after 45 minutes of running. IAB was inspected and had no sign of perforation. No blood was seen in helium line. Helium tank was not empty. All connections check and secure. Patient not tachycardic or febrile.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472848 ↗
• MalfunctionJul 27, 2026Failure to Calibrate; Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50032092 ↗
• MalfunctionFeb 19, 2026No Display/Image

  IT WAS REPORTED BY CUSTOMER DURING USE THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD INTERMITTENT GREEN SCREEN. THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387270 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD CATHETER OCCLUSION FAULT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374640 ↗
• MalfunctionFeb 6, 2026Inability to Auto-Fill

  IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE TESTING THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS AN ISPB FILL ERROR FAULT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277239 ↗
• MalfunctionJan 30, 2026Insufficient Cooling

  IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECKING THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD FAN FAILURE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219923 ↗
• MalfunctionDec 28, 2025Break; Failure to Read Input Signal; Break; Failure to Read Input Signal

  IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD DAMAGED IV POLE CONNECTOR DURING ROUTINE CHECK, NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903367 ↗
• MalfunctionDec 22, 2025Overheating of Device; Unexpected Shutdown; Overheating of Device; Unexpected Shutdown

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863376 ↗
• MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775729 ↗
• MalfunctionDec 2, 2025Calibration Problem; Output below Specifications; Key or Button Unresponsive/not Working; Calibration Problem; Output below Specifications; Key or Button Unresponsive/not Working

  CPH RP CARDIOSAVE POWER UP TEST FAILED, 11.11.2025; CARDIOSAVE POWER UP TEST FAILED. NO ONE WAS HARMED. WE ARE WAITING FOR THE CUSTOMER TO APPROVE THE QUOTE TO GO ONSITE. ONCE THE QUOTE IS APPROVED AND THE FSE GOES ONSITE, MORE INFORMATION CAN BE REQUESTED BY THE RELEVANT FSE CARDIOSAVE HYBRID TYPE I PLUG TECHNICIANS REMARKS: WD: 2019-11-01, CT: NULL, SO1D 2025-10-02, SO2D 2024-11-07.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692758 ↗
• MalfunctionDec 2, 2025Image Display Error/Artifact; No Apparent Adverse Event; Image Display Error/Artifact; No Apparent Adverse Event

  IT WAS REPORTED DURING ROUTINE TESTING THAT CARDIOSAVE IABP MAINTENANCE REQUIRED ALARM IN THE DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692384 ↗
• MalfunctionNov 26, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Communication or Transmission Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658771 ↗
• MalfunctionNov 4, 2025Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466924 ↗
• MalfunctionOct 31, 2025Calibration Problem; Appropriate Device Problem Term/Code Not Available; Calibration Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY FSE THAT DURING PM THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM REGULATOR FAULT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433655 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Device Contamination with Body Fluid; Fluid/Blood Leak; Device Contamination with Body Fluid

  IT WAS REPORTED THAT IN CARDIOSAVE INTRA AORTIC BALLOON PUMP THERE WAS BLOOD INSIDE, BLOOD WAS SUCKED INSIDE THE MACHINE, NO PATIENT WAS HARMED OR INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936982 ↗
• MalfunctionAug 26, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING SETUP ON PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DID NOT DISPLAY THE PRESSURE WAVEFORM WHEN USING FIBRE OPTIC OR PRESSURE TRANSDUCER. HOWEVER, NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898484 ↗
• MalfunctionAug 6, 2025No Device Output; Connection Problem; No Device Output; Connection Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731680 ↗
• MalfunctionAug 5, 2025Power Problem; Power Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714868 ↗
• MalfunctionAug 2, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED BY CUSTOMER THAT DURING ROUTINE CHECK, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BLACK CIRCLE ON SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693843 ↗