CS300 Intra-Aortic Balloon Pump - UTS, English, 110V 0998-00-3023-83Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10607567108285), received between Jun 23, 2021 and Jun 2, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES OF CS300 INTRA-AORTIC BALLOON PUMP (IABP) DID NOT LAST FOR PM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122679 ↗
• MalfunctionJul 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19775228 ↗
• MalfunctionApr 18, 2024Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT DURING USE ON A PATIENT AT THE INITIATION OF THERAPY, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTO FILL FAILURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134831 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT DURING NON-PATIENT TRANSPORT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS DROPPED AND NEEDS SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210989 ↗
• MalfunctionAug 7, 2023Appropriate 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 17470494 ↗
• MalfunctionJul 18, 2023Erratic or Intermittent Display; Pressure Problem; Erratic or Intermittent Display; Pressure Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 17342395 ↗
• MalfunctionMay 26, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT PRIOR TO USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009108 ↗
• MalfunctionMar 10, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A PRESSURE PORT ISSUE. IT IS UNKNOWN ABOUT THE PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16522140 ↗
• MalfunctionFeb 24, 2023Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED DURING A ROUTINE, THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOFILL FAILURE. THEE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 16435524 ↗
• MalfunctionFeb 17, 2023Battery Problem; Battery Problem

  IT WAS REPORTED DURING A ROUTINE CHECK PERFORMED BY MARK HARPER THE CS300 UNIT HAS BATTERY ISSUES. NO PATIENT INVOLVEMENT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396768 ↗
• MalfunctionNov 11, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS BATTERIES DID NOT LAST THROUGHOUT ENTIRE PM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781532 ↗
• MalfunctionNov 9, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS BLURRY AT THE LOWER HALF AND WILL NOT CLEAR WITH TROUBLESHOOTING.

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

  MAUDE report 15765517 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A BROKEN ARTERIAL LINE PLUG AND CRACKED HOUSING.

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

  MAUDE report 15411217 ↗
• MalfunctionAug 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS NOT FUNCTIONAL. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF THERE WAS ANY PATIENT INVOLVEMENT.

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

  MAUDE report 15175165 ↗
• InjuryApr 18, 2022Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT DURING USE ON A PATIENT USING A CS300 INTRA-AORTIC BALLOON PUMP (IABP), THE PATIENT WAS IN CARDIAC ARREST AND THE CONSOLE GENERATED AN AUTOFILL FAILURE ALARM. THE CUSTOMER CONFIRMED THAT THE HELIUM CONNECTIONS WERE SECURE, THE SAFETY DISK WAS SCREWED IN TIGHTLY, AND THE IAB FILL PORT LUER LOCK CONNECTION WAS SECURE. THE HELIUM TANK WAS NOT EMPTY AND WAS OPEN, BUT THE PUMP WOULD NOT AUTOFILL. THE PHYSICIAN DECIDED TO REMOVE THE IAB AND REPLACE IT WITH A NEW ONE. THE SECOND IAB WAS INSERTED SUCCESSFULLY, BUT THE CONSOLE GENERATED AN AUTOFILL FAILURE ALARM ONCE AGAIN. ALL CONNECTIONS WERE AGAIN CONFIRMED SECURE. THE HELIUM TANK WAS NOT EMPTY AND WAS OPEN, BUT THE PUMP STILL WOULD NOT AUTOFILL. THE CUSTOMER WAS INSTRUCTED TO ATTEMPT A MANUAL FILL WITH 40CC AIR USING A 50CC SYRINGE AND 3-WAY STOPCOCK. THE CUSTOMER PERFORMED THE MANUAL FILL WITHOUT ANY ISSUES AND NO RESISTANCE WAS REPORTED. HOWEVER, AFTER THE SUCCESSFUL MANUAL FILL, THE PUMP AGAIN GENERATED AN AUTOFILL FAILURE ALARM. THE PHYSICIAN DECIDED TO HAVE THE PATIENT TRANSPORTED TO A DIFFERENT FACILITY WITH THE SECOND IAB STILL INSERTED, NOT CONNECTED TO A PUMP. AT THIS TIME, THE CUSTOMER HAS NOT ATTRIBUTED T

  Patient problems: Cardiac Arrest

  MAUDE report 14135724 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A CRACKED SCREEN. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF A PATIENT WAS INVOLVED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772640 ↗
• MalfunctionJun 23, 2021Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049317 ↗