CARDIOSAVE HYBRID TYPE J PLUG 0998-00-0800-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10607567111117), received between Oct 7, 2020 and Sep 30, 2026 — classified as 2 deaths, 46 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (5 reports).

21 FDA recall records name this device's identifier, 21 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 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 ↗

6. 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 ↗

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 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

    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. Apr 4, 2023Class IIOpen, Classified

    The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

    Z-1462-2023 · Root cause: Component design/selection · 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 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 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 ↗

17. 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 ↗

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 ↗

21. 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 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 turn on. No patient was involved and no harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that when attempting to turn on the equipment, the screen remains black. At times, the screen turns white, but then returns to black, with a constant alarm sounding. Errors presented indicate a possible failure in the Executive Processor Board, requiring replacement of the board. The device also had no batteries. Equipment not released for use, awaiting replacement of Executive Processor Board and Batteries. Prior to this event, the equipment had been out of service for over a year, remaining switched off and stored in the warehouse. The current Clinical Engineering team is new and therefore has no history or information about what previously occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943770 ↗
• DeathApr 15, 2026Inability to Auto-Fill; Inflation Problem; Battery Problem

  IT WAS REPORTED THAT DURING A CARDIAC SURGICAL PROCEDURE, THE CARDIOSAVE HYBRID INTRA AORTIC BALLOON PUMP (IABP) DISPLAYED AN ¿AUTOMATIC FILL FAILURE¿ ERROR. ACCORDING TO THE HOSPITAL¿S CLINICAL ENGINEERING MANAGER, THE PATIENT DID NOT RESPOND FOLLOWING RETURN FROM EXTRACORPOREAL SURGERY. THE CLINICAL TEAM ATTEMPTED TO USE THE CARDIOSAVE DEVICE FOR REVERSAL; HOWEVER, THE DEVICE DISPLAYED AN AUTOMATIC INFLATION FAILURE ERROR AND COULD NOT BE USED. NO ADVERSE EVENT WAS INTERNALLY RECORDED BY THE INSTITUTION AT THE TIME OF THE OCCURRENCE. THE PATIENT DIED. NURSING STAFF DID NOT CONFIRM THAT THE PATIENT¿S DEATH WAS A CONSEQUENCE OF THE DEVICE ERROR.

  Patient problems: Insufficient Information

  MAUDE report 24884887 ↗
• MalfunctionApr 6, 2026Communication or Transmission Problem; Appropriate Device Problem Term/Code Not Available; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791847 ↗
• MalfunctionMar 26, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PREVENTIVE MAINTENANCE REVEALED CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) SAFETY DISC WAS ABOUT TO EXPIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696559 ↗
• MalfunctionMar 23, 2026Unexpected Shutdown

  IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) TURNED OFF DURING USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662506 ↗
• MalfunctionFeb 12, 2026Electrical /Electronic Property Problem; Failure to Calibrate; Key or Button Unresponsive/not Working

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320484 ↗
• MalfunctionDec 19, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT CARDIOSAVE HYBRID TYPE J PLUG INTRA-AORTIC BALLOON PUMP (IABP) ALARMING BATTERY MAINTENANCE EVEN THOUGH BATTERY WERE REPLACED, DURING USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847392 ↗
• MalfunctionNov 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT GOT OVERHEATED, 43 DEGREES CELSIUS, ALARMED. THE PUMP WAS NO LONGER OPERABLE AND COULD ONLY BE TURNED OFF. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540428 ↗
• MalfunctionOct 27, 2025Leak/Splash; Failure to Power Up; Leak/Splash; Failure to Power Up

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389856 ↗
• MalfunctionJun 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT DURING DAILY EQUIPMENT CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), SEVERAL PARTS WERE FOUND TO BE WORN OUT OR HAD REACHED THE END OF THEIR LIFE CYCLE, NECESSITATING IMMEDIATE REPLACEMENT TO ENSURE THE EQUIPMENT OPERATES SAFELY AND RELIABLY. NO PATIENT INVOLVED.

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

  MAUDE report 22163736 ↗
• MalfunctionJun 3, 2025Output Problem; Appropriate Device Problem Term/Code Not Available; Output Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING MAINTENANCE THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) MAY NEED MAINTENANCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131959 ↗
• MalfunctionJun 2, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT CARDIOSAVE INTRA AORTIC BALLOON PUMB (IABP) WAS ALARMING BECAUSE OF SYSTEM HEATING.

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

  MAUDE report 22123341 ↗
• MalfunctionDec 27, 2024Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DURING THE TECHNICAL VISIT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DID NOT PASS BATTERY TEST AND THE SAFETY DISC WAS EXPIRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025883 ↗
• MalfunctionJul 20, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE BY HOSPITAL PERSONNEL, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS AN INTERNAL COMMUNICATION ERROR BUT TREATMENT CONTINUED AFTER RESTARTING.

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

  MAUDE report 19786161 ↗
• MalfunctionJul 18, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT DURING AN EMERGENCY CASE LATE, AFTER PCI WAS COMPLETED, THE PATIENT WAS BEING MANAGED IN THE EMERGENCY DEPARTMENT ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WHEN THE EMERGENCY DEPARTMENT CONTACTED THE OMINATO CE, WHO SAID THAT ALTHOUGH IT WAS AC-POWERED, FOR SOME REASON IT WAS RUNNING ON BATTERY POWER AND WAS SHOWING 25 MINUTES REMAINING, SO THE BALLOON WAS REPLACED WITH ANOTHER PUMP IN THE HOSPITAL AND TREATMENT CONTINUED. THE OMINATO CE RETURNED TO THE CE CENTER, PLUGGED IT INTO AN OUTLET AND CHARGED IT FOR ABOUT THREE HOURS, BUT WHEN HE RETURNED AND TRIED TO TURN IT ON, IT WOULD NOT TURN ON.

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

  MAUDE report 19775173 ↗
• MalfunctionMay 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS LEAKING IN PIM MODULE.

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

  MAUDE report 19240326 ↗
• MalfunctionApr 9, 2024Power Problem; Power Problem

  IT WAS REQUESTED BY CUSTOMER FOR A TECHNICAL VISIT OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IS BELIEVED TO HAVE A PROBLEM WITH THE POWER SUPPLY.

  Patient problems: Insufficient Information

  MAUDE report 19072620 ↗
• MalfunctionMar 28, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING AN UNRELATED SERVICE CALL PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NEW BATTERIES WERE DEFECTIVE AFTER ABOUT THREE MONTHS. THE CUSTOMER HAD A LOANER BATTERY FROM THE RENTAL DEVICE UNTIL THE BATTERIES WERE DELIVERED. THE CUSTOMER ALSO HAD A BATTERY FOR BRIDGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992391 ↗
• MalfunctionFeb 1, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) RECOGNIZES POWER SUPPLY, BUT IS NOT CHARGING THE BATTERIES. THE DEVICE WAS PARKED IN CLINICAL ENGINEERING AND NOT IN USE. WHEN THEY WENT TO WORK ON THE EQUIPMENT, THEY NOTICED THE DEFECT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624515 ↗
• MalfunctionJan 5, 2024Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455651 ↗
• MalfunctionDec 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372497 ↗
• MalfunctionNov 14, 2023Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHEN CHECKING THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WITH A NON-STERILE DEMO CATHETER, THE ADAPTER FOR THE CATHETER EXTENSION WAS PREVIOUSLY LOOSENED WITH A CLAMP WHEN TRYING TO UNSCREW IT. THE PNEUMATIC MODULE WAS DESTROYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133266 ↗
• MalfunctionNov 9, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A FAILURE ALARM OVERHEATING .

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

  MAUDE report 18105860 ↗
• MalfunctionOct 26, 2023Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT DURING TESTS BY HOSPITAL ENGINEER THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) PRESENTS SEVERAL DEFECTS RELATED TO CHARGING AND DISCHARGE OF BATTERIES, PRESENTING FUNCTIONS LOCKDOWN. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 18013857 ↗
• MalfunctionSep 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING UNRELATED SERVICING BY THE GETINGE FIELD SERVICE ENGINEER (GFSE), WHEN INITIALIZING THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IT SHOWED A START-UP TEST FAILURE WITH CODE 05. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844529 ↗