CARDIOSAVE RESCUE 0998-00-0800-83Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 10607567108407), received between Aug 28, 2020 and Aug 28, 2026 — classified as 167 malfunctions.

The most frequently reported specific device problem is “Break” (26 reports).

26 FDA recall records name this device's identifier, 26 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-0917-2026 · 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-0932-2026 · 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-3135-2024 · 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-3137-2024 · 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-2432-2023 · 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, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.

   Z-2436-2023 · 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 reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

   Z-2434-2023 · Root cause: Device Design · Recall details · FDA record ↗

10. 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 ↗

11. 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 ↗

12. 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 ↗

13. 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-2487-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Jul 31, 2023Class IOpen, Classified

    Users were identifying autofill failure conditions on the devices causing pump stops.

    Z-2438-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. 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-2152-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

16. 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-2150-2023 · Root cause: Device Design · Recall details · FDA record ↗

17. 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-1277-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

18. 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-1148-2023 · Root cause: Software design · Recall details · FDA record ↗

19. 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-1146-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

20. 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-1232-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗

21. 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 ↗

22. 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-1230-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

23. 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-0886-2023 · Root cause: Device Design · Recall details · FDA record ↗

24. 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-0337-2022 · Root cause: Device Design · Recall details · FDA record ↗

25. 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 ↗

26. Sep 20, 2018Class IOpen, Classified

    There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

    Z-0100-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Failure to Read Input Signal; Charging Problem; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495033 ↗
• MalfunctionAug 17, 2026Failure to Read Input Signal

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275152 ↗
• MalfunctionApr 13, 2026Gas/Air Leak

  (B)(6) CALLED INTO EMERGENCY SUPPORT PROGRAM LINE WITH A REOCCURRING GAS LOSS ALARM. SHE STATED THEY WERE ON THE WAY TO THE AIRPORT TO FLY THE PATIENT APPROXIMATELY 2 HOURS TO DENVER. SHE BELIEVED THE ISSUE WAS RESOLVED AFTER USING THE IAB FILL KEY AND TURNING OFF THE GAS ALARM. ESP PERSONNEL VERIFIED NO BLOOD OR DISCOLORATION IN THE HELIUM TUBING AND ADVISED TURNING THE GAS LOSS ALARM BACK ON. THE PUMP IMMEDIATELY ALARMED GAS LOSS AND REQUIRED REPEATED CHECKS AND IAB FILL TO RESUME FUNCTION. THE PATIENT WAS VENTILATED AND ON TRANSPORT WHEN THE ALARM RECURRED. THE BALLOON WAS CONFIRMED AS AN ARROW 40 CC WITH CORRECT 30-40 CC DRIVE ADAPTOR TUBING ALREADY REPLACED. UPON ARRIVAL AT THE AIRPORT ESP PERSONNEL OUTLINED OPTIONS TO RETURN TO THE HOSPITAL OR CONTINUE TRANSPORT WITH THE GAS ALARM OFF PER IFU SINCE NO BLOOD WAS PRESENT. A SCREEN SHOT SHOWED SUBOPTIMAL AUGMENTATION AND ATYPICAL WAVEFORM PROMPTING RECOMMENDATION TO CONFIRM BALLOON PLACEMENT ON ARRIVAL. AT 2-06 AM TRACI CONFIRMED THE PATIENT ARRIVED AT THE CVICU AT UC ANSHUTZ WHERE PLACEMENT WAS VERIFIED BUT GAS LOSS ALARMS PERSISTED ON A SECOND PUMP. ESP PERSONNEL ADVISED THIS WAS LIKELY A BALLOON ISSUE AND RECOMMENDED TELEFLEX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853899 ↗
• MalfunctionApr 9, 2026Electrical /Electronic Property Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD BLANK LOWER SCREEN- TOUCHSCREEN CONSOLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828124 ↗
• MalfunctionApr 7, 2026No Device Output; Battery Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP) MALFUNCTIONED. BATTERY AND FIBER-OPTIC CABLE HAS BEEN REPORTED AS MALFUNCTIONED. THERE WAS NO PATIENT INVOLVED REPORTED.

  Patient problems: Bone Cement Implantation Syndrome; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797504 ↗
• MalfunctionMar 19, 2026Signal Artifact/Noise; Failure to Analyze Signal

  IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD NO ECG SIGNAL. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638591 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA AORTIC BALLON PUMP(IABP) MOUNT LOOSE. POPUP MOUNT HAS A LOSS 4 SCREWS. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619164 ↗
• MalfunctionJan 23, 2026Charging Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT CHARGING WHEN HOOKED UP TO AC POWER.THERE WAS NO PATIENT INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158643 ↗
• MalfunctionJan 12, 2026Overheating of Device

  IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SYSTEM OVER TEMPERATURE ALARM. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034481 ↗
• MalfunctionDec 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK ISSUE PRIOR TO USE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903408 ↗
• MalfunctionDec 14, 2025Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ISSUE WHERE THE RED CABLES WERE BENT AND NOT FUNCTIONING WHILE THE DEVICE WAS IN USE. THERE WAS PATIENT INVOLVED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799193 ↗
• MalfunctionDec 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLON PUMP(IABP) HAD HELIUM ISSUE WHILE DEVICE WAS DURING USE. THERE WAS PATIENT INVOLVED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799191 ↗
• MalfunctionOct 30, 2025Inability to Auto-Fill; Gas/Air Leak; Material Twisted/Bent; Inability to Auto-Fill; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK WHEN TRYING TO FILL WITH AN EXTERNAL SUPPLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423649 ↗
• MalfunctionOct 30, 2025Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421551 ↗
• MalfunctionOct 15, 2025Battery Problem; Battery Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287930 ↗
• MalfunctionSep 9, 2025Disconnection; Intermittent Communication Failure; Disconnection; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING USE ON PATIENT CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD OCCURRED INTERNAL COMMUNICATION ERROR AND MULTIPLE LEAD DISCONNECTIONS. THERE WAS NO HARM OR INJURY REPORTED TO THE PATIENT.

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

  MAUDE report 23003432 ↗
• MalfunctionSep 5, 2025Electrical /Electronic Property Problem; Communication or Transmission Problem; Electrical /Electronic Property Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PM BY GENTINGE FSE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD OCCURRED ERROR CODE 139. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975910 ↗
• MalfunctionJun 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN INTERNAL HELIUM LEAK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334154 ↗
• MalfunctionJun 11, 2025Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED AN AUTOFILL FAILURE. NO HARM REPORTED.

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

  MAUDE report 22182786 ↗
• MalfunctionMay 19, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WON¿T CHARGE.

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

  MAUDE report 22041848 ↗
• MalfunctionMay 6, 2025Failure to Zero; Failure to Zero

  IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS UNABLE TO ZERO PRESSURE LINE WHILE ON PATIENT. PATIENT WAS TRANSPORTED WITHOUT ISSUE AND UNIT SET ASIDE ONCE PATIENT WAS OFF IABP. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966648 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER PRIOR TO USE THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP SCREEN HINGES ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891049 ↗
• MalfunctionApr 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FIBRE OPTIC PORT IS BROKEN. THERE WERE NO INDICATION OF ACTUAL OR POTENTIAL HARM OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771203 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS DAMAGED FROM FRONT DUE AS IT WAS DROPPED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717844 ↗
• MalfunctionMar 10, 2025Material Integrity Problem; Material Integrity Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558013 ↗