CARDIOSAVE RESCUE, CHINESE 0998-00-0800-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10607567112312), received between May 9, 2024 and Mar 2, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 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. 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 ↗

2. 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 ↗

3. 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 ↗

4. 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 ↗

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 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 ↗

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-2432-2023 · Root cause: Under Investigation by firm · 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-2487-2023 · 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-2438-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. 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 ↗

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 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 ↗

13. 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 ↗

14. 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 ↗

15. 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 ↗

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-1230-2023 · 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 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 ↗

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. 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 ↗

20. 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 ↗

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-1507-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Failure to Power Up

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478792 ↗
• MalfunctionJul 25, 2025Overheating of Device; Pressure Problem; Noise, Audible; Overheating of Device; Pressure Problem; Noise, Audible

  IT WAS REPORTED THAT DURING THE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD THE COMPRESSOR IS UNABLE TO PROVIDE NORMAL PRESSURE, WITH A MAXIMUM POSITIVE PRESSURE NOT EXCEEDING 400MMHG, RESULTING IN SEVERE PERFORMANCE DEGRADATION OF THE COMPRESSOR. AFTER INSTALLATION, THE PERFORMANCE DOES NOT MEET THE STANDARDS, THERE IS ABNORMAL NOISE FROM THE ACCESSORIES, AND THE PRESSURE IS INSUFFICIENT. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607067 ↗
• MalfunctionJun 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DURING THE INSPECTION REPORTED THAT AUTOMATIC INFLATION WAS RESTRICTED. THERE WAS NO PERSONAL INJURY. PATIENT NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326702 ↗
• MalfunctionMar 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE INSPECTION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS CDS SCREEN WAS DAMAGE. THERE WAS NO PATIENT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558637 ↗
• MalfunctionFeb 24, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP HAD A INTERMITTENT ECG SIGNAL DURING USE. THE ECG SIGNAL WAS SOMETIMES AVAILABLE AND SOMETIMES NOT. THE ELECTRODE POSITION WAS ADJUSTED AND THE CONNECTION WAS CHECKED. THE FAULT STILL EXISTED. THE ELECTRODE WAS ATTACHED TO THE HEAD NURSE FOR ON-SITE TESTING. THE ELECTRODE FAULT WAS INDEED REPORTED AFTER A WHILE. THE SIGNAL WAS RESTORED BY SLIGHTLY MOVING THE LEAD WIRE CLIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444366 ↗
• MalfunctionJan 16, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP HAD AN ISSUE OF BATTERY COULD NOT BE CHARGED, THAT WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166915 ↗
• MalfunctionJan 10, 2025Inflation Problem; Inflation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21121743 ↗
• MalfunctionNov 13, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) MACHINE WAS TURNED ON, AN ELECTRICAL FAULT 14 WAS FOUND DURING ROUTINE INSPECTION. NO PATIENTS INVOLVED, NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20680012 ↗
• MalfunctionNov 6, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) LITHIUM BATTERY WAS FOUND TO BE DAMAGED WHEN THE INSTRUMENT WAS CHARGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620235 ↗
• MalfunctionNov 6, 2024Failure to Power Up; Failure to Power Up

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620094 ↗
• MalfunctionSep 18, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED AND FAILED, INDICATING THAT THE MACHINE TEMPERATURE WAS TOO HIGH. IT WAS STOPPED AND REPLACED WITH A SPARE MACHINE THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249593 ↗
• MalfunctionMay 9, 2024Failure to Power Up; Charging Problem; Power Problem; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Charging Problem; Power Problem; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282209 ↗