CS100 Intra-Aortic Balloon Pump, Portuguese, 110V 0998-00-3013-69Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10607567107769), received between Sep 25, 2020 and Aug 16, 2026 — classified as 1 injury, 65 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (8 reports).

8 other recalls cover devices cleared under the same FDA submission (K031636); they may or may not involve this specific model.

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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Display or Visual Feedback Problem

  It was reported by customer that the CS100 Intra-Aortic Balloon Pump (IABP) had a defective display. No harm and injury was reported. It was found that, after a period of use, the unit exhibited display character faults, causing the characters to become garbled. Internal cleaning of the circuit boards and their connections was performed. Afterward, the equipment ran through cycles for 3 hours and showed no further operational abnormalities. Equipment released for use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268459 ↗
• MalfunctionAug 14, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254692 ↗
• MalfunctionFeb 20, 2026No Display/Image

  IT WAS REPORTED BY CUSTOMER THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS DISPLAYING A BLACK SCREEN UPON STARTUP. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398247 ↗
• MalfunctionFeb 11, 2026No Display/Image; Output below Specifications; Power Problem

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS HAVING ISSUE WITH ON/OFF SWITCH, WHICH IS CAUSING MACHINE TO SHUTDOWN. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311407 ↗
• MalfunctionFeb 9, 2026Image Display Error/Artifact; Unexpected Shutdown

  IT WAS REPORTED THAT DISPLAY WITH CHARACTERS NOT VISIBLE ON THE CS100 INTRA-AORTIC BALLOON PUMP(IABP). AFTER INSPECTION IT WAS FOUND THAT THE EQUIPMENT SHUT DOWN AFTER ABOUT 10 MINUTES OF USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290062 ↗
• MalfunctionNov 26, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  N/A - NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656198 ↗
• MalfunctionNov 12, 2025Display or Visual Feedback Problem; Visual Prompts will not Clear; Display or Visual Feedback Problem; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING DAILY CLEANING, CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS DISPLAY FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531746 ↗
• MalfunctionSep 9, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS NOT READING PRESSURE PARAMETER. NO PATIENT HARM/INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004170 ↗
• MalfunctionJul 30, 2025Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662215 ↗
• MalfunctionJul 25, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT IN CS100 INTRA AORTIC BALLOON PUMP, THERE WAS A INTERFERENCE WITH DISPLAY, THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607740 ↗
• MalfunctionJun 27, 2025Mechanical Problem; Failure to Read Input Signal; Battery Problem; Calibration Problem; Mechanical Problem; Failure to Read Input Signal; Battery Problem; Calibration Problem

  IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS DISPLAYING AN ERROR MESSAGE "MAINTENANCE REQUIRED, CODE 5, NO TRIGGER SIGNAL, BATTERY MAINTENANCE REQUIRED. EQUIPMENT DID NOT RECOGNIZE BATTERY CHARGE.

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

  MAUDE report 22344436 ↗
• MalfunctionJun 23, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN WAS CHANGING THE DISPLAY CHARACTERS.

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

  MAUDE report 22305844 ↗
• MalfunctionJun 6, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A UNEXPECTED SHUTDOWN.

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

  MAUDE report 22158023 ↗
• MalfunctionMay 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED CHARACTERS WITH FAULTS ON THE SCREEN WHEN STARTING UP THE EQUIPMENT. THERE WAS NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095065 ↗
• MalfunctionMay 8, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD VACUUM LOSS.

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

  MAUDE report 21984043 ↗
• MalfunctionMay 8, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD LOW VACUUM ALARM.

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

  MAUDE report 21983926 ↗
• MalfunctionApr 21, 2025Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING INSPECTION BY THE CUSTOMER THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ISSUE WITH ELECTRICAL TEST FAILURE, ERROR 53 THAT DIAGNOSE X1 TRANSDUCER HAS A VALUE BELOW THAT STATED IN THE MANUAL, APPROXIMATELY 50. PATIENT INVOLVEMENT IS UNKNOWN.

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

  MAUDE report 21872119 ↗
• MalfunctionApr 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  N/A

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

  MAUDE report 21871673 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT BEFORE USE THE GLASS OF BLOOD DETECTOR HOSE OF CS100 INTRA AORTIC BALLOON PUMP(IABP) WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444532 ↗
• MalfunctionJan 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY GETINGE FIELD SERVICE ENGINEER (FSE), CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS NO RECORD OF WHEN THE 5000-HOUR ENGINE KIT AND LEAD-ACTION BATTERIES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155951 ↗
• MalfunctionNov 27, 2024Charging Problem; Charging Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800365 ↗
• MalfunctionNov 27, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD 4 CART CASTER WHEELS THAT WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791347 ↗
• InjuryOct 25, 2024Premature Discharge of Battery; Obstruction of Flow; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Power Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS A POWER SUPPLY ISSUE. THE PATIENT WAS IN BED. IT PRESENTS ALARM IN MONITORING, THE INTRAORTIC BALLOON (IABP) WAS DISCONNECTED. IAB PLACED IN ANOTHER SOCKET, AND IT RETURNS WITH INTERFERENCE ON THE SCREEN REGARDING MAINTENANCE. DUE TO THE INCIDENT, THE PATIENT IS RESPONSIVE. AT 2 AM PATIENT WORSENS TO CRP, CPR MANEUVERS BEGIN. PULSE PRESENT AND STOPPED CHEST COMPRESSION MANEUVERS, CONTINUED RECEIVING NORADRENALINE 50ML, AND INITIATED POST-PCR PROCEDURES. THE BATTERY DID NOT CHARGE AFTER THE DEVICE WAS TURNED OFF. THE PATIENT WAS TRANSFERRED TO ANOTHER LOCATION AND ANOTHER IABP. THE PATIENT WAS REPORTED AS STABLE AS OF FOLLOW UP 2 WEEKS AFTER THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 20538725 ↗
• MalfunctionOct 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS AN INTERNAL LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531489 ↗
• MalfunctionOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible; Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  IT WAS REPORTED THAT BEFORE USE DURING ROUTINE CHECKS, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DOESN'T CYCLE AND IS MAKING NOISE. THERE WAS NO DAMAGE TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031636. One submission often covers many models, so check the product and lot details in each record.

• Z-1486-2026 · Jan 23, 2026 · Open, Classified
  CS100 IABP. Software Version CS100 IABP Q.01.
• Z-3086-2017 · Jul 17, 2017 · Open, Classified
  CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by au
• Z-3085-2017 · Jul 17, 2017 · Open, Classified
  CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by a
• Z-2736-2017 · Jun 16, 2017 · Terminated
  CS 100i Intra-Aortic Balloon Pump
• Z-2737-2017 · Jun 16, 2017 · Terminated
  CS 100 Intra-Aortic Balloon Pump
• Z-1523-2014 · Mar 21, 2014 · Terminated
  Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate in
• Z-2414-2011 · Mar 16, 2011 · Terminated
  Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 130
• Z-1811-2010 · May 10, 2010 · Terminated
  CS100 Intra-Aortic Balloon Pump.