CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 10,316 adverse event reports that list this exact device (DI 10607567108391), received between Jan 6, 2020 and Sep 30, 2026 — classified as 39 deaths, 20 injuries, 10,255 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (1,604 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 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 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 ↗

8. 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 ↗

9. 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 ↗

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

    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 ↗

15. 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 ↗

16. 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 ↗

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 ↗

21. 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-0099-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 10,316 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946110 ↗
• MalfunctionSep 30, 2026No Device Output

  It was reported by the customer that during clinical use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Waveforms and ECG were reported to be blurred. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE was not able to reproduce the customer's stated issue. This is the second call with the same issue. The FSE replaced the Display Assembly for precautionary purposes. Functionality was tested without any failures or issues. Safety, calibration, and functionality checks to factory specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945570 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported by customer that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) experienced a Gas Loss in IAB Circuit Alarm. There was patient involved. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed gas loss message on reported date in logs. Could not duplicate the reported issue. Product passed all functional and safety tests per manufacturer specifications. Pump was exchanged to continue treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945343 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported by the customer that during routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a suspected helium leak. No patient was involved and no harm was reported. Information was received from the customer that initial checks by the biomedical engineering technician revealed a significant leak. A service call was placed for the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943664 ↗
• MalfunctionSep 30, 2026Inability to Auto-Fill; No Device Output; Gas/Air Leak

  It was reported that during use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) experienced a Gas Loss in IAB Circuit Alarm. Patient involvement. No harm is reported. The Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. It was reported that Gas Loss message was confirmed in logs. FSE found also logs related to fiber optic module and autofill failure. To address issue fiber optic module was replaced. Unit passed all functional and safety tests performed. Unit cleared for use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943589 ↗
• MalfunctionSep 30, 2026Device Contamination with Body Fluid; Obstruction of Flow

  During an Emergency Support Program call, a CCU RN contacted Clinical Support regarding connection of an Arrow IAB catheter to a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) after the patient was transferred from an outside hospital using a Teleflex pump. The customer reported that the helium connection was not compatible and requested guidance on transferring therapy to the CARDIOSAVE without returning the patient to the catheterization laboratory. The required Driveline Tubing Adapter and appropriate size selection were reviewed, along with the connection process. After the IAB was transferred from the Teleflex pump to the CARDIOSAVE, a Catheter Restriction alarm occurred. Before additional troubleshooting could be performed, the customer reported observing thick, dark orange fluid coming from the IAB Catheter Extender Input. The customer was advised to reconnect the IAB to the original pump, obtain a new CARDIOSAVE for exchange, and label the affected pump for Biomedical Engineering evaluation. FSE was dispatched to evaluated the unit, confirmed blood back event. Blood intrusion spotted in all pneumatic components. Pneumatic interface module, Pneumatic lineset, reservoir, fitting

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943038 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  During an Emergency Support Program call, a CTICU RN reported a Gas Loss alarm on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during use. The customer reported that Perfusion had evaluated the system and that the patient and pump were otherwise functioning appropriately; however, the Gas Loss alarm caused the pump to enter Standby for approximately 10-15 seconds. The customer verified that there was no blood in the helium tubing, all connections were secure and appropriate, and no visible kinks were present in the tubing. The nature of the Gas Loss alarm was reviewed, and based on the reported clinical condition, the alarm was discussed as potentially related to changes in intrathoracic pressure. Recommended troubleshooting steps were reviewed, and the customer was advised to contact Clinical Support if the alarm recurred several times within one hour. The customer was appreciative of the support. No patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942938 ↗
• MalfunctionSep 30, 2026Device Contamination with Body Fluid

  The Getinge Field Service Engineer (FSE) was informed by the customer that the device has suffered a bloodback event recently and that the PIM was swapped. No blood was observed within the pump by FSE. The customer qualified technician had resolved that issue prior to Getinge FSE visit.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942856 ↗
• MalfunctionSep 30, 2026Power Problem

  It was reported by Getinge Field Service Engineer (FSE) that during preventive maintenance (PM) the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had frayed power cord. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE performed 5k PM with replacement of power cord reel assembly due to nick in cord. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942854 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported that during use the CARDIOSAVE Intra Aortic Balloon Pump (IABP) displayed Gas loss in IAB circuit. There was no reported harm or injury. FSE evaluated the unit and noticed that, the Compressor was sluggish and slow to come up to pressure. The Compressor and the expired safety disk and tidal volume disk were replaced. Unit passed all the tests.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942853 ↗
• MalfunctionSep 30, 2026Gas/Air Leak; Unexpected Shutdown

  It was reported that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. No harm reported. Unit stopped working while alarming and was unable to troubleshoot. Patient was put on another known good unit to avoid therapy delay. Onsite, FSE could not confirm what alarm was alarming during use. Initial power up and run of unit had no issues. However, there was a gas loss alarm along with technical error 118 in the background. As a pre caution the power management board was replaced for error code 118. Unit was then Ran for a couple hours and no issues occurred or alarms. Verified unit passed manufacturer specs, unit returned to customer. No other patient information provided. FSE completed repair successfully. Product passed all functional and safety tests per manufacbturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942626 ↗
• MalfunctionSep 30, 2026Inability to Auto-Fill; Gas/Air Leak

  It was reported that during pre use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Autofill failure and gas loss has been reported. There was no patient involvement reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942357 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931314 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931248 ↗
• MalfunctionSep 29, 2026Failure to Read Input Signal

  It was reported by the customer that during pre use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Fiber optic reported to be damaged. No harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930954 ↗
• MalfunctionSep 29, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930093 ↗
• MalfunctionSep 29, 2026Charging Problem

  It was reported that during use the CARDIOSAVE Intra Aortic Balloon Pump (IABP) batteries stopped charging. After this event occurred, this IABP unit was continued to be used throughout IABP therapy for this patient. As this IABP unit was connected to AC power source, this event did not affect continuing IABP therapy. There was no patient harm. A Getinge Field Service Engineer (FSE) evaluated the unit and found that the Power Management Board, which controls power and charging, was faulty. Therefore, the Power Management Board was replaced. After the replacement, multiple discharge/charge cycles were repeated, and charging was confirmed to be normal. After the work was completed, an inspection was conducted based on the service manual, with good results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929828 ↗
• MalfunctionSep 29, 2026Leak/Splash; Sparking; Power Problem

  It was reported by the customer that during a routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) plug sparked a bit with no fire. No patient was involved. No harm was reported. Line cord was arcing and smoking when plugged into the AC outlet. FSE Found what looked like evidence of saline on line cord plug. Line cord assembly was replaced. Defective part is being sent for manufacturer evaluation of the failure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929649 ↗
• MalfunctionSep 29, 2026Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  It was reported by the customer that before use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) (b)(6) ¿kept beeping all the time¿. No patient was involved. The customer contact person was unable to provide any more information regarding patient/user harm or the discovery of this issue. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE identified significant system failures in the device logs: Fault # 124 (Pneumatics generated system failure - Prolonged Shuttle Prs System Failure) and Fault # 58 System Failure - Shutdown. Based on the FSE's assessment, these errors occurred due to pressure being applied to the shuttle transducer when the shuttle should be open to atmosphere (have zero gauge pressure). But both vacuum and shuttle transducers were at 27mmHg gauge at atmospheric pressure. Condensation removal procedure (CRP) was performed, which caused a small change. The FSE attempted 30 PSI transducer calibration, but it was not possible. The FSE performed multiple CRPs again. The transducers were then at 16 mmHg. The PIM leak test and All Manifolds Test passed. The FSE attempted 30 PSI transducer calibration again, and this time it was successful.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929508 ↗
• MalfunctionSep 29, 2026Pumping Problem; Intermittent Communication Failure

  It was reported by the customer that during therapy the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) stopped pumping. A patient was involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE arrived on site and analyzed device logs. Fault Code # 106 (Communication error in the software data center) was recorded several times. The FSE was unable to replicate any issue when testing on a patient simulator and test catheter. Executive Processor PCBA was replaced as a precaution. B.17 software was reinstalled, 30psi and helium transducers were recalibrated. Product passed all functional and safety tests per manufacturer specifications. The replaced Executive Processor PCBA will be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929478 ↗
• MalfunctionSep 29, 2026Device Contamination with Body Fluid

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929354 ↗
• MalfunctionSep 29, 2026Mechanical Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929124 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  It was reported by the customer that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Helium tank leaking multiple times has been reported. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that device found to have a leak of approximately 15 PSI in 5 minutes. Found staff using plastic tank seals, which were replaced. Tightened the easily accessible helium connections to the cart¿s helium regulator and tested again. Product passed all functional and safety tests per manufacturer specifications. Returned to customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929123 ↗
• MalfunctionSep 29, 2026Display or Visual Feedback Problem

  It was reported by the customer that the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. No patient involved. No harm reported. Screen not working has been reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that unable to replicate reported issue. Both display test and touch screen test passed without issue multiple times. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928836 ↗
• MalfunctionSep 29, 2026Device Contamination with Body Fluid

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928390 ↗