CARDIOSAVE HYBRID TYPE M PLUG 0998-00-0800-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10607567109107), received between Apr 15, 2021 and Jul 29, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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.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 were identifying autofill failure conditions on the devices causing pump stops.

   Z-2437-2023 · 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 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 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

    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. 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

    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 ↗

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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Device Contamination with Body Fluid

  It was reported that the patient underwent an angiogram, and an Intra-Aortic Balloon (IAB) catheter was inserted for therapy with CARDIOSAVE Intra-Aortic Balloon Pump (IABP) unit. The following day, blood was observed in the helium tubing while the patient was being repositioned. The pump continued to operate without generating any alarms. The pump was placed in standby, and the helium tubing was clamped. An attempt to remove the catheter was unsuccessful, requiring surgical removal. A large clot was identified during the procedure, and an additional 5 cm groin incision was required to facilitate catheter removal. The patient remained stable following the procedure.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 50067333 ↗
• MalfunctionMar 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD UPPER DISPLAY IN A DIFFERENT COLOR THAN NORMAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662657 ↗
• MalfunctionAug 22, 2023Overheating of Device; Overheating of Device

  N/A.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596048 ↗
• MalfunctionAug 10, 2023Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED BY CUSTOMER ON MONDAY EVENING (24 JULY 2023) THE REPRESENTATIVE OF GAUTENG WAS CONTACTED REGARDING AN AUTOFILL FAILURE ERROR ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). WHEN THEY INITIALIZED THE THERAPY THE AUTOFILL FAILURE ERROR ALARMED. THEY FOLLOWED THE HELP SCREEN INSTRUCTIONS ON THE PUMP AND AS LAST RESORT THEY SWAPPED OUT THE BALLOONS TO ESTABLISH IF IT WAS THE CONSUMABLE, BUT EVEN WITH REPLACING OF THE BALLOON THEY GOT THE SAME ERROR. AT THIS TIME THE REPRESENTATIVE WAS CONTACTED, AND SHE DID SOME MORE TROUBLESHOOTING OVER VIDEOCALL WITH THEM. HELIUM WAS CHECKED, TUBING USED, IAB FILL WAS DONE AND EVEN MANUAL FILL OF THE BALLOON, BUT THE ERROR PERSISTED. AP WAVEFORM AS WELL AS ECG WAS TRACED ON THE PUMP. THE THERAPY WAS STOPPED DUE TO THE FACT THAT THE CUSTOMER DOES NOT HAVE A BACKUP PUMP, CARDIOSAVE WAS BOUGHT WITHOUT A BACKUP UNIT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497171 ↗
• MalfunctionJul 14, 2023Gas/Air Leak; Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324566 ↗
• MalfunctionJun 12, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM OVER TEMPERATURE, ALARM. MACHINE MAKES HIGH PITCHED SOUND AND GOES INTO STANDBY. HELP BUTTON SAYS SWITCH MACHINE OFF. WAIT FOR IT TO COOL OFF AND RESUME THERAPY. HAPPENED IN EARLY HOURS OF MORNING AND THEN AGAIN AROUND 07H00. THE STAFF SWITCHED THE MACHINES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107164 ↗
• MalfunctionMay 30, 2023Failure to Charge; Failure to Charge

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021145 ↗
• MalfunctionJan 30, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING INSTALLATION THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED TO RECOGNIZE THE NEW BATTERY. THE BATTERY WAS SWAPPED BETWEEN BAYS AND THE ERROR MOVED WITH THE BATTERY. A BATTERY FROM AN ALREADY INSTALLED CARDIOSAVE WAS INSERTED INTO THE NEW UNIT TO OBSERVE IF THE ISSUE WAS THE BATTERY OR THE NEW UNIT. THE ERROR REMAINED ON BAY 1 REGARDLESS OF THE BATTERIES INSERTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264567 ↗
• MalfunctionSep 12, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A HELIUM LEAK.

  Patient problems: Insufficient Information

  MAUDE report 15402728 ↗
• MalfunctionAug 31, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A HELIUM LEAK ON CART VALVE.

  Patient problems: Insufficient Information

  MAUDE report 15328872 ↗
• MalfunctionMar 1, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A SYSTEM OVER TEMPERATURE MESSAGE, THEN POWERED OFF. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638692 ↗
• MalfunctionApr 16, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANNUAL PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED THE FIRST STAGE OF THE DRIVE MANIFOLD LEAK TEST. THE UNIT DID NOT ALARM FOR THE REPORTED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679705 ↗
• MalfunctionApr 15, 2021Failure to Sense; Output Problem; Appropriate Device Problem Term/Code Not Available; Failure to Sense; Output Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PRE-DELIVERY INSPECTION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED THE 2ND PORTION OF THE FILL MANIFOLD TEST. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674732 ↗