CS300 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOM 0998-UC-3023-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10607567108704), received between Aug 27, 2021 and Apr 7, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026No Device Output

  IT WAS REPORTED THAT THE CS300 INTRA AORTIC BALLOON PUMP(IABP) HAD OPTICAL SENSOR FAILURE MESSAGE ON THE DISPLAY. THERE HAD PATIENT INVOLVEMENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797007 ↗
• MalfunctionSep 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931831 ↗
• MalfunctionMay 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRIOR TO USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD IAB DISCONNECT ALARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094155 ↗
• MalfunctionMay 23, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DISPLAYS SCREEN GOES BLACK AFTER TURNING ON.

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

  MAUDE report 22077491 ↗
• MalfunctionMar 27, 2025Inability to Auto-Fill; Difficult or Delayed Positioning; Failure to Calibrate; Inability to Auto-Fill; Difficult or Delayed Positioning; Failure to Calibrate

  IT WAS REPORTED BY CUSTOMER DURING USE THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) THE PUMP IS ALARMING "CHECK IAB CATHETER" AND HAS BEEN IN STANDBY FOR SEVERAL MINUTES. THE DEVICE HAD AUTOFILL FAILURE AND UNABLE TO CALIBRATION MESSAGE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705726 ↗
• MalfunctionMar 26, 2025Battery Problem; Optical Problem; Battery Problem; Optical Problem

  IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECK THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) COVER TO FIBER OPTICS BROKEN AND WARNING BATTERY MAINTENANCE REQUIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695449 ↗
• MalfunctionFeb 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY GETINGE FIELD TECHNICIAN THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DIAGNOSE UNITS FOR ISSUES. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444850 ↗
• MalfunctionFeb 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING INITIAL DIAGNOSE SERVICE SCHEDULE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DIAGNOISED WITH ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443796 ↗
• MalfunctionDec 4, 2024Battery Problem; Battery Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840502 ↗
• MalfunctionOct 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A DISTORTED DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480384 ↗
• MalfunctionJan 30, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608751 ↗
• MalfunctionSep 20, 2023Electrical /Electronic Property Problem; Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S SHUTTLE PURGE FAILED AND HAD LOW PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783064 ↗
• MalfunctionSep 8, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED BATTERY RUNTIME TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712751 ↗
• MalfunctionJun 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED LEAK TEST. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCE THE EVENT OCCURRED AND IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 17151701 ↗
• MalfunctionMay 4, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY FAILED RUN TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869766 ↗
• MalfunctionMar 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SEIZED HARDWARE ON SAFETY DISK. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 16471285 ↗
• MalfunctionFeb 3, 2023Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT DID NOT PASS TEST, DIED AT 90 MINUTES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16298191 ↗
• MalfunctionMay 13, 2022Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A FIBER OPTIC ISSUE. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399589 ↗
• MalfunctionMar 9, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED DURING ROUTINE CHECK THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S DISPLAY WAS GLITCHING AND HAD LINES GOING THROUGH IT. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712973 ↗
• MalfunctionAug 27, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377476 ↗