CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 456 adverse event reports that list this exact device (DI 10607567113432), received between Sep 15, 2022 and Sep 30, 2026 — classified as 3 deaths, 1 injury, 452 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (62 reports).

20 FDA recall records name this device's identifier, 20 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 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 ↗

7. 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 ↗

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 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. 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 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 ↗

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 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 ↗

20. 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 456 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) alarmed Gas Loss in IAB Circuit. Patient involved and no harm is reported. Unit was swapped and treatment was continued using a different CARDIOSAVE unit. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that they performed a leak test, but the result was similarly ¿Failure".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944263 ↗
• MalfunctionSep 30, 2026Crack

  It was during preventive maintenance performed by a Getinge Field Service Engineer (FSE) the CARDIOSAVE Intra Aortic Balloon Pump (IABP) exterior of the new lithium-ion battery was cracked when opening the box. The problem was solved by using another lithium-ion battery. All functional and safety test passed. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943772 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported by the FSE that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) helium gas rapidly decreased due to improper storage. After the helium cylinder was replaced with a new one, the issue reoccurred. The FSE reported that they could not reproduce the issue. As a precaution, the gasket was replaced and it was confirmed that the helium was not leaking. There will be no part return. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943039 ↗
• MalfunctionSep 28, 2026Unexpected Shutdown

  It was reported by customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) shutdown. There was patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that battery was not charged, but can be recharged. The device currently appears to be working without problems, it remains under service evaluation and monitoring.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913731 ↗
• MalfunctionSep 28, 2026Display or Visual Feedback Problem

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a problem with the screen display. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed the white discoloration with blue line on the LCD. The FSE replaced the LCD. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912490 ↗
• MalfunctionSep 23, 2026Failure to Read Input Signal

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) did not display direct ECG input. Patient involved and no harm is reported. Unit was swapped and there was no impact on the patient or the treatment. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that they inspected the device but were unable to reproduce the problem. This time, the ECG cable (green connector) + MiniSIM (simulation) did not receive a signal input. FSE connected the (Letter) and performed testing, but they were unable to reproduce the symptoms. FSE also checked the signal input of the external input (MONI-X cable), but there were no problems. Pumping operation via direct ECG input is OK. No abnormalities were found in the CARDIOSAVE or ECG cables this time. Device is now back in a condition suitable for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864907 ↗
• MalfunctionSep 21, 2026Charging Problem

  It was reported that during routine inspection the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Battery charging failure has been reported. The issue disocovered by Field Service Engineer (FSE). No patient involved. No harm reported. The FSE reported that the battery level in slot 2 was completly empty. Battery wont charge while conneted to the AC. When another battery was inserted in slot 2 battery charged normally. After battery replacement, battery and charging functions are working correctly. No fault logs available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835456 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  It was reported by the customer that during inspection the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. The fiber connector section need adjusting. No patient involved and no harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835211 ↗
• MalfunctionSep 18, 2026Communication or Transmission Problem; Pumping Problem

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had an internal communication error, causing the equipment to stop working. The unit was swapped to continue treatment. Patient involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that upon checking the logs, Fault #115 (Kernal API Error) occurred at the time. The device is currently under repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813851 ↗
• MalfunctionSep 17, 2026Failure to Power Up; Charging Problem

  It was reported by the customer that prior to use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) won't power on after pressing power button to start using it for an emergency case. Patient was involved and no harm is reported. Treatment was initiated using alternative equipment within the hospital. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The device was checked and it was confirmed that it was neither charging the device or receiving power. The FSE suspected a malfunction with power management board. After replacing it, no issue with powering on and off or charging was noted. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798051 ↗
• MalfunctionSep 16, 2026Failure to Read Input Signal

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had Intra-Aortic Balloon (IAB) Optical Sensor Malfunction alarm. As a result, arterial pressure measurement via the optical sensor became unavailable. Patient ECG electrode became detached, resulting in loss of the ECG trigger source. The IABP automatically switched to internal trigger mode and therapy continued without interruption. Reconnecting the optical sensor connector multiple times did not resolve the alarm. Use of the optical sensor was discontinued and arterial pressure monitoring was switched to an external pressure input. After completion of the PCI procedure, the patient was transferred to the ICU and continues to receive IABP therapy under temporary pacing support. No injury reported. After reconnecting the optical sensor, there seemed to be no further problems, and the device-related concerns were resolved over the phone. The customer cancelled the visit.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785618 ↗
• MalfunctionSep 15, 2026Device Contamination with Body Fluid

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had drawn blood into it form a ruptured third party balloon. Patient involved and no harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772373 ↗
• MalfunctionSep 14, 2026Gas/Air Leak

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) helium gas loss message occurred. There was patient involvement. No harm was reported. It was reported that pump was replaced, the clinical staff kept the same balloon and replaced the CARDIOSAVE unit.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752300 ↗
• MalfunctionSep 11, 2026Display or Visual Feedback Problem; No Device Output

  It was reported that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a display distortion. Patient involved and no harm is reported. The issue recurred after restarting the device and as a precaution, the device was replaced and treatment continued. The issue discovered by the customer. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported display malfunctions (ECG, arterial pressure noise, and touchscreen). The relevant circuit boards have been cleaned and reconnected. During the repair, it was confirmed that a foreign object resembling a hair was found inside the upper display. As this was confirmed, and considering the possibility that it may have contributed to the current issue, the upper display was also replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726965 ↗
• MalfunctionSep 10, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707864 ↗
• MalfunctionSep 10, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707534 ↗
• MalfunctionSep 1, 2026Device Contamination with Body Fluid

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540870 ↗
• MalfunctionSep 1, 2026Charging Problem

  It was reported that during routine check by the customer, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned and battery 1 was not charging, even though the power cable was connected. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) evaluated the unit for the reported malfunction.Upon testing, it was found that the base for power management (AC/DC switching, charging control) has failed. Failure has been detected in the Power Management Board. After replacement of the Power Management Board, the FSE performed multiple discharge and charge tests and the results were satisfactory. Both batteries 1 and 2 were able to operate for more than 80 minutes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539263 ↗
• MalfunctionSep 1, 2026Electrical /Electronic Property Problem; Failure to Sense; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538074 ↗
• MalfunctionAug 31, 2026Image Display Error/Artifact

  It was reported by the customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) the display showed noise or flickering at the top of the screen. No harm and injury was reported. The Getinge FST was dispatched to evaluate the unit. It was reported that FSE was unable to reproduce the reported issue. No abnormalities were found, connections inside the monitor were suspected but display board and monitor cable were replaced as a precaution. All functional and safety checks have been performed to factory specifications and the unit has been returned to use. Unit was used until end of treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524428 ↗
• MalfunctionAug 31, 2026Failure to Sense; Failure to Read Input Signal; Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515912 ↗
• MalfunctionAug 26, 2026Inability to Auto-Fill

  It was reported by the customer that during clinical use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) displayed an "Automatic Filling Error." Patient was involved. No harm was reported. There was no device change in treatment. The IABP was rebooted, and the error was reported to have cleared. The reported error recurred when a test balloon was connected to the IABP after completion of therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50448794 ↗
• MalfunctionAug 24, 2026Mechanical Problem; Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419280 ↗
• MalfunctionAug 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50394139 ↗
• MalfunctionAug 23, 2026Image Display Error/Artifact

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50394090 ↗