CS100 Intra-Aortic Balloon Pump, English, 110V 0998-00-3013-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 10607567107394), received between Aug 27, 2020 and Sep 29, 2026 — classified as 1 death, 1 injury, 377 malfunctions.

The most frequently reported specific device problem is “Inability to Auto-Fill” (37 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 379 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Noise, Audible

  It was reported that during general check up the CS100 Intra Aortic Balloon Pump (IABP) had noise. There was no patient involvement and no adverse event reported. The FSE found abnormal noise in the pump and unit usage was more than 10000 Hours, So 5000 Hours Pump PM Kit was replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930196 ↗
• MalfunctionSep 16, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785917 ↗
• MalfunctionSep 16, 2026Inability to Auto-Fill

  It was reported that the CS100 Intra-Aortic Balloon Pump (IABP) had Autofill error. It is unknown when the malfunction occurred. There is no information about patient involvement. No harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785849 ↗
• MalfunctionSep 14, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the customer that the CS100 Intra-Aortic Balloon Pump (IABP) gave an error: maintenance required, code 9. It is unknown when the malfunction occurred. No patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that they were not able to reproduce the error occurred. As per manual, they removed and replaced the fiber optic module as required. Completed repair successfully. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749858 ↗
• MalfunctionAug 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495281 ↗
• MalfunctionAug 28, 2026Unexpected Shutdown

  It was reported by the customer that prior to use, the CS100 Intra-Aortic Balloon Pump (IABP) malfunctioned. Unit experienced a System Failure during Autofill. There was no patient involved. Device was tested by biomed, and fault was not reproducible. Biomed performed full testing and everything is passing. The FSE provided customer the recommended parts to order as precaution. The customer has ordered the recommended parts and will perform the repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493877 ↗
• MalfunctionAug 14, 2026Device Alarm System; Inability to Auto-Fill; Gas/Air Leak

  It was reported by the customer that, the CS100 Intra-Aortic Balloon Pump (IABP) notified alarms but no alarm codes given. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that no alarm codes were given. FSE was not able reproduce the issue. During evaluation, gas loss alarm was also reported. FSE was not able to find any unit issues. Completed repair successfully. Product passed all functional and safety tests per manufacturer specifications. Returned unit to customer for use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252809 ↗
• MalfunctionAug 11, 2026Signal Artifact/Noise; Improper Flow or Infusion

  It was reported by the customer through the Emergency Support Program (ESP) that during use, the CS100 Intra-Aortic Balloon Pump (IABP) exhibited a damped arterial waveform, loss of augmentation/support, and multiple alarms. There was patient involvement reported, and no injury or harm was reported. The customer reported that augmentation pressures had initially been in the 110s before the arterial waveform suddenly became damped and adequate support could no longer be obtained. An augmentation alarm was observed on Pump 1, and the customer initiated an exchange to Pump 2. Following the exchange, an "Unable to Update Timing" alarm was observed on Pump 2 (SA03479-B5). ESP personnel instructed the customer to place the console in standby, aspirate and flush the arterial pressure line using the transducer for 20-30 seconds, and restart the pump. Following these actions, the arterial waveform quality immediately improved and the alarm resolved. Troubleshooting determined that the catheter and pumps were functioning as intended and that the reported condition was not associated with a device malfunction but rather with line maintenance/user-related factors. ESP personnel reviewed line m

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206138 ↗
• MalfunctionApr 14, 2026Battery Problem

  IT WAS REPORTED BY CUSTOMER DURING BEFORE USE THAT THE CS300 INTRA AORTIC BALLOON PUMP (IABP) HAD A BATTERY MAINTENANCE REQUIRED MESSAGE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868247 ↗
• MalfunctionApr 1, 2026Inability to Auto-Fill

  IT WAS REPORTED THAT THE CS100 HAD AUTOFILL FAILURE ALARM, PRIOR TO USE. AUTOFILL FAILURE CAUSED BY LEAK IN THE CATHETER THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758579 ↗
• MalfunctionMar 17, 2026Gas/Air Leak

  IT WAS REPORTED DURING USE THAT CS300 HAD INTERMITTENT ALARM LEAK IN FILL LINE. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614512 ↗
• MalfunctionMar 16, 2026Inability to Auto-Fill; Decrease in Pressure

  IT WAS REPORTED BY CUSTOMER THAT THE CS100 INTRA AORTIC BALLOON PUMP(IABP) FAILED AUTOFILL BEFORE USE. DURING TESTING FOUND THE AVERAGE PRESSURE LOW. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602804 ↗
• MalfunctionFeb 23, 2026Inability to Auto-Fill

  IT WAS REPORTED BY THE CUSTOMER THAT DURING PRIOR TO USE THE CS100 INTRA-AORTIC BALLOON PUMP(IABP) UNIT DID NOT ALARM WHEN TRYING TO FILL WITH HELIUM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412501 ↗
• MalfunctionJan 28, 2026Premature Discharge of Battery

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197440 ↗
• MalfunctionJan 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK ISSUE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065535 ↗
• MalfunctionJan 12, 2026Battery Problem

  IT WAS REPORTED BY THE CUSTOMER THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY DYING WHILE WALKING DURING USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035147 ↗
• MalfunctionJan 5, 2026Failure to Power Up

  IT WAS REPORTED BY THE CUSTOMER THAT PRIOR TO USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) UNIT WILL NOT POWER ON. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954919 ↗
• MalfunctionJan 3, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE CUSTOMER THAT BATTERIES FAILING PREMATURELY DURING THERAPY FOR THE CS100 INTRA-AORTIC BALLOON PUMP(IABP). THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952907 ↗
• MalfunctionDec 27, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT CS300BATTERY GOES FROM 100 PERCENT TO ZERO IN FIVE MINUTES. NO PATIENT INVOLVEMENT OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901468 ↗
• MalfunctionDec 27, 2025Image Display Error/Artifact; Image Display Error/Artifact

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901454 ↗
• MalfunctionDec 12, 2025Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  IT WAS REPORTED THAT THE CS100 HAD SYSTEM FAILURE ERROR ISSUE DURING ROUTINE CHECK CUSTOMER FOUND THE ISSUE. THERE WAS NO PATIENT INVOLVED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791445 ↗
• MalfunctionDec 9, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE, CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WILL NOT TURN ON. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759155 ↗
• MalfunctionDec 9, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WON'T CHARGE ABOVE 50%. LEFT UNIT ON ON CHARGER OVERNIGHT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756441 ↗
• MalfunctionDec 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A DEMAND PM ALERT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739890 ↗
• MalfunctionDec 8, 2025Charging Problem; Charging Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739831 ↗