CARDIOSAVE HYBRID - TYPE "N" PLUG 0998-00-0800-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10607567114187), received between Sep 4, 2024 and Sep 24, 2026 — classified as 1 death, 15 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (8 reports).

9 FDA recall records name this device's identifier, 9 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 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 ↗

6. 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 ↗

7. 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 ↗

8. 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 ↗

9. 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 ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Insufficient Cooling

  It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a ¿Fan fault detected ¿ Switch to another Maquet IABP, if available, and contact Maquet Technical Support¿ message. Patient was involved, no harm reported. The treatment was completed. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the fan located above the motor had an abnormal vibration. As the fans had been replaced in the field action, it was decided that both fans would be replaced with the new ones. After the replacement, the equipment cycled for more than 4 hours and did not present any further messages or any abnormalities in its operation. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882202 ↗
• MalfunctionSep 1, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538703 ↗
• MalfunctionAug 17, 2026Noise, Audible

  It was reported by the customer that during routine check, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Unit is making a noise when starting up. There was no patient involvement reported.Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. During the evaluation, the FSE addressed the reported noise by replacing Drive Manifold Assembly (P/N: 0104-00-0031). Following the repair, the device was confirmed to be operating properly and was released to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272067 ↗
• DeathFeb 2, 2026Failure to Power Up; Battery Problem; Unexpected Shutdown

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 24233885 ↗
• MalfunctionNov 13, 2025Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A BATTERY MAINTENANCE REQUIRED MESSAGE. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540474 ↗
• MalfunctionNov 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED BY CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYS THE MESSAGE BATTERY MAINTENANCE REQUIRED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540354 ↗
• MalfunctionOct 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT IABP CATHETER FAILED DURING THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322143 ↗
• MalfunctionOct 16, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE ON PATIENT, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS OVERHEATING ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307994 ↗
• MalfunctionOct 15, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING ROUTINE CHECK, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS SHOWING BATTERY FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300848 ↗
• MalfunctionJul 14, 2025Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT DISPLAYED A MESSAGE THAT IABP MAY NEED MAINTAINANCE. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492564 ↗
• MalfunctionMay 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED DURING A ROUTINE EQUIPMENT CHECK THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A BATTERY MAINTENANCE MESSAGE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042551 ↗
• MalfunctionMay 13, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DOES NOT FINISH ITS INITIALIZATION, THE SCREEN KEEPS TRYING TO COMMUNICATE WITH THE EXECUTE BOARD AND FAILS IN SEQUENCE AFTER 3 ATTEMPTS, CHARACTERS ARE DISAPPEARING ON THE DISPLAY.

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

  MAUDE report 22011120 ↗
• MalfunctionFeb 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AFTER UPDATE THE EQUIPMENT STOPPED RECOGNIZING THE BATTERY, CHANGING SLOTS THE DEFECT CHANGES TOGETHER IN THE BATTERY STATUS IT APPEARS CHARGED. THERE AS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342156 ↗
• MalfunctionFeb 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING ROUTINE CHECK, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) STOPPED RECOGNIZING THE BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341682 ↗
• MalfunctionJan 31, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING CLEANING OF THE CARDIOSAVE INTRA AORTIC BALLOON PUMP, ERROR MESSAGE RELATED TO BATTERY TEST WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281653 ↗
• MalfunctionSep 4, 2024Inability to Auto-Fill; Inability to Auto-Fill

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133842 ↗