CS300 Intra-Aortic Balloon Pump, Portuguese, 220V 0998-00-3023-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10607567108353), received between Sep 4, 2020 and Apr 10, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (7 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EQUIPMENT ALARMED DURING USE AND EQUIPMENT WAS ALSO REQUESTING BATTERY TEST. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843694 ↗
• MalfunctionMar 12, 2026Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING PREVENTIVE MAINTENANCE THAT THE CS300 IABP DISPLAYED ERROR 7. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577781 ↗
• MalfunctionJan 21, 2026Break; Erratic or Intermittent Display; Display or Visual Feedback Problem; Loose or Intermittent Connection

  IT WAS REPORTED THAT CS300, TYPE B PLUG INTRA-AORTIC BALLOON PUMP (IABP)¿S MONITOR WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128254 ↗
• MalfunctionJan 21, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT DURING THE EVALUATION AND TECHNICAL TESTING PERIOD, THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) EQUIPMENT INDICATED THAT THE CYLINDER NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127994 ↗
• MalfunctionDec 29, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V INTRA-AORTIC BALLOON PUMP (IABP) WILL ONLY RUN ON BATTERIES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904182 ↗
• MalfunctionSep 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DOWN WITH SCREEN PROBLEM AND SHAKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082511 ↗
• MalfunctionSep 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY GETINGE FSE THAT DURING PM THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FAILED PNEUMATIC PERFORMANCE TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070238 ↗
• MalfunctionAug 8, 2025Failure to Read Input Signal; Battery Problem; Output Problem; Failure to Read Input Signal; Battery Problem; Output Problem

  IT WAS REPORTED THAT CS300 MACHINE SIDE ECG SOCKET NOT WORKING & BATTERY BACK UP IS TOO LOW. ECG IS NOT WORKING AND REQUIRED BATTERY REPLACEMENT. NO PATIENT INVOLVED. NO ONE WAS HARMED ONSITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747537 ↗
• MalfunctionAug 6, 2025Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOFILL FAILURE ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

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

  MAUDE report 22724682 ↗
• MalfunctionJul 24, 2025Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE CS300 INTRA AORTIC BALLOON PUMP (IABP) DISPLAYED AN AUTOFILL ERROR. NO PATIENT INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591939 ↗
• MalfunctionApr 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING ROUTINE CHECK 98XT UPGRADED INTO CS300 INTRA AORTIC BALLOON PUMP (IABP), THE DISPLAY WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932717 ↗
• MalfunctionMar 13, 2025Component Incompatible; Output Problem; Component Incompatible; Output Problem

  IT WAS REPORTED THAT DURING ROUTINE CHECK THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHOWS LOW VACUUM ERROR. NO PATIENT INVOLVED. NO ONE WAS HARMED ONSITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592319 ↗
• MalfunctionMar 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582455 ↗
• MalfunctionMar 11, 2025Battery Problem; Battery Problem

  N/A

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

  MAUDE report 21570309 ↗
• MalfunctionMar 4, 2025Battery Problem; Battery Problem

  IT WAS REPORTED BY GETINGE FST DURING PREVENTIVE MAINTENANCE THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERIES WORN OUT IN 3 YEARS LESS. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512127 ↗
• MalfunctionFeb 20, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN DURING TREATMENT TWICE WITHOUT ANY AUDIBLE ALARM. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419117 ↗
• MalfunctionFeb 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY GETINGE FIELD SERVICE TECHNICIAN, THAT DURING PREVENTIVE MAINTENANCE CHECK, THE MONITOR OF CS300 IABP (INTRA-AORTIC BALLOON PUMP) WAS FLICKERING ON AND OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409146 ↗
• MalfunctionFeb 19, 2025Noise, Audible; Noise, Audible

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408986 ↗
• MalfunctionFeb 11, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING USE THE CS300 INTRA AORTIC BALLOON PUMP (IABP) UNIT WAS BEEPING. PATIENT INVOLVED AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354255 ↗
• MalfunctionJan 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING THE PREVENTIVE MAINTENANCE THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) TAB FOR FIXING THE IABP TO THE TROLLEY WAS MISSING AND THAT THE BATTERIES WERE COMPLETELY DISCHARGED DUE TO THE EQUIPMENT NOT BEING CONNECTED TO THE MAINS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216435 ↗
• MalfunctionJan 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED PRIOR TO USE THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT INFLATING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176709 ↗
• MalfunctionJan 2, 2025Failure to Zero; Failure to Zero

  IT WAS REPORTED BY THE CUSTOMER THAT DURING DAILY TESTING CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNABLE TO ZERO PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052958 ↗
• MalfunctionJan 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS SHOWING EMPTY HELIUM ON THE SCREEN EVEN THOUGH THE GAGE WAS REFLECTING FULL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21050758 ↗
• MalfunctionDec 3, 2024No Display/Image; No Display/Image

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832396 ↗
• MalfunctionDec 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON WEDNESDAY 11/29/2023, AN ADVERSE EVENT OCCURRED WITH THE CS300 INTRA- AORTIC BALLOON PUMP(IABP) THE PATIENT WAS HAVING A CARDIAC ARREST AND THEY WERE TRYING TO INSTALL THE EQUIPMENT IN IT. DURING THE PROCESS THE BALLOON DID NOT WORK PROPERLY, DISPLAYING "SYSTEM FAILURE" MESSAGE CAUSING AN AUDIBLE WARNING. IN THE HELP MENU A MESSAGE WAS DISPLAYED THAT STATED "INCORRECT OPERATION OF THE MICROPROCESSOR" AND PROVIDING THE ACTION TO RESTART THE EQUIPMENT AND HOLD FOR 10 SECONDS. IT WAS DONE AND THE ERROR PERSISTED. AN ATTEMPT TO SYNCHRONIZE THE AUTO , PRESSURE AND ECG FUNCTIONS AND NONE OF THESE OPTIONS , THE EQUIPMENT WAS ABLE TO START THE TREATMENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317454 ↗