CS100 Intra-Aortic Balloon Pump, English, 220V 0998-00-3013-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 933 adverse event reports that list this exact device (DI 10607567107295), received between Sep 8, 2020 and Sep 30, 2026 — classified as 4 deaths, 1 injury, 928 malfunctions.

The most frequently reported specific device problem is “Inability to Auto-Fill” (112 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 933 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Failure to Power Up

  It was reported by the customer that during routine check the CS100 Intra-Aortic Balloon Pump (IABP) is not switching ON. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that after checking the unit found that, unit giving Long Beep sound and not switching ON. The FSE found one blown fuse. After replacing the same found power supply is Ok but motor control board is defective. FSE replaced motor control board. Unit passed all functional and safety tests as per manufacturer¿s specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944459 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Material Integrity Problem

  It was reported by the customer that the CS100 Intra-Aortic Balloon Pump (IABP) had an ECG signal interference. There is no information about patient involvement, no harm was reported. The customer is requesting a price quote for a set of ECG cables. The customer stated that the old cable appears to be worn.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942706 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  It was reported that during a routine check by the customer, the CS100 Intra-Aortic Balloon Pump (IABP) had a helium leak. There was no patient involvement and no harm reported. There was a leak at the connection between the apparatus and the helium cylinder. The part indicated by the service engineer for replacement was the helium tank O-ring. This will be replaced during scheduled preventative maintenance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928947 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  It was reported that during routine check by customer, the CS100 Intra-Aortic Balloon Pump (IABP) malfunctioned. Helium leak has been reported. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that issue was caused by O-ring.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928720 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  It was reported by the customer that during a routine check the CS100 Intra-Aortic Balloon Pump (IABP) had an external helium leak from the cylinder. No patient was involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. It was reported that helium gas manifold washer was damaged. The washer was replaced from the customer's available stock. After replacing the washer, FSE connected the helium gas supply to the system and carried out all necessary safety checks. All safety parameters were found OK, and the valve leakage test was also completed successfully. The system was then checked with patient support, and everything was found working properly. After confirming normal operation, the system was handed over to the department in good working condition. No parts for return reported. No fault logs are available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928496 ↗
• MalfunctionSep 29, 2026Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928291 ↗
• MalfunctionSep 23, 2026Material Integrity Problem

  It was reported by the customer that during routine check the CS100 Intra-Aortic Balloon Pump (IABP) ECG cable was found to be broken. No patient involved and no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed that the cable is broken. The cable is pending replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866334 ↗
• MalfunctionSep 22, 2026Failure to Power Up

  It was reported by the customer that during routine check, the CS100 Intra-Aortic Balloon Pump (IABP) was not switching on. There was no patient involvement reported, no harm reported. A Getinge Field Service Engineer (FSE) evaluated the unit. The FSE identified a damaged fuse and replaced it. The FSE also checked the connections and connectors for the power supply, main board, display board, and ON/OFF switch, and all were found to be properly connected. As the unit still required further troubleshooting, the power supply was suspected to be defective. The FSE replaced the Motor Control Board and Power Supply. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850985 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem

  It was reported by the customer that during routine check the CS100 Intra-Aortic Balloon Pump (IABP) malfunctioned. Electrical test Fail code 65 and 66 has been reported. No patient involvement. No harm reported. The Field Service Engineer (FSE) reported that suspected problem was in the main board. Replacement is needed for testing purposes. After replacing PCB main board and performing all tests, issue was resolved. Handed over unit in proper working order.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835910 ↗
• MalfunctionSep 17, 2026Battery Problem; Power Problem

  It was reported by customer that during a routine check up, the CS100 Intra-Aortic Balloon Pump (IABP) did not turn on when plugged into an AC power outlet. The was no patient involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE found that the AC power cord was damaged, the repair was conducted. The device was tested and found to be functional but the safety disc battery ome parts were worn out and past their lifespan. Safety Disk is worn out and has reached the end of its lifespan. The battery for the IABP is worn out (expired) and the device cannot be used with the battery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801566 ↗
• MalfunctionSep 16, 2026Charging Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785066 ↗
• MalfunctionSep 14, 2026Mechanical Problem; Battery Problem; Appropriate Device Problem Term/Code Not Available; Failure to Deflate

  It was reported by the customer that during a routine check, a Low Vacuum Alarm was detected during a balloon test of the CS100 Intra-Aortic Balloon Pump (IABP). There was no patient involvement and no harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that upon opening the Drive Manifold, it was found that the contacts of the Solenoid Valve Assembly were contaminated with carbon deposits from the pressure-generating rubber of the pump unit. This caused the contacts to not close properly, resulting in a low vacuum alarm. The FSE cleaned the contacts of solenoid valves K7 and K8. The unit passed all functional and safety tests to manufacturer specifications. However, replacement of the 5,000h Maintenance Kit is recommended, as the device has exceeded 5000 hours of use without its replacement. It was noted that the pressure-generating rubber component which has deteriorated and is accumulating soot is part of the 5,000h Maintenance Kit. Additionally, the battery is showing signs of deterioration, and its replacement is recommended. A quote has been provided to the customer and is pending acceptance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751974 ↗
• MalfunctionSep 10, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713180 ↗
• MalfunctionSep 1, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541641 ↗
• MalfunctionAug 28, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495824 ↗
• InjuryAug 28, 2026Device Alarm System; Fluid/Blood Leak

  It was reported that during an angiogram CS300 Intra-Aortic Balloon Pump (IABP) had difficulty in remove the balloon. There was dried out blood spots in the helium tubing. The doctor was notified and they attempted to remove the balloon in ICU and in theatre without any success. The patient had to be airlifted to another hospital where there was a vascular surgeon on call and the balloon had to be removed surgically in theatre. At no point were there any alarms on the pump to notify the customer that there are blood detected or helium loss. After our technician inspected the pump no alarms appeared relating to the incident and the pump was filled with blood on the inside.

  Patient problems: Insufficient Information

  MAUDE report 50495823 ↗
• MalfunctionAug 12, 2026Inability to Auto-Fill; Obstruction of Flow

  It was reported by the customer that during use the CS100 Intra Aortic Balloon Pump experienced an Autofill Failure and Check IAB Catheter alarm. There was patient involvement; however, no harm or adverse event was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221282 ↗
• MalfunctionAug 12, 2026Material Integrity Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219205 ↗
• MalfunctionMay 18, 2026Image Display Error/Artifact

  IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECK THAT THE CS100 INTRA AORTIC BALLOON PUMP (IABP) SCREEN FLICKERS WHEN THE DEVICE IS TURNED ON. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197246 ↗
• MalfunctionMay 13, 2026Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECKS THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD HELIUM LEAK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157659 ↗
• MalfunctionMay 6, 2026Inability to Auto-Fill

  IT WAS REPORTED THAT A CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD AN AUTO FILL FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091027 ↗
• MalfunctionApr 13, 2026Naturally Worn

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A WORN-OUT SAFETY DISK AND 5000 HR MAINTENANCE KIT. THERE WAS NO PATIENT INJURY OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858039 ↗
• MalfunctionApr 7, 2026Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY FSE DURING ROUTINE CHECKS THAT THE CS100 IS NOT GETTING SWITCHED OFF. UNIT TESTED AND SEEMS POWER SUPPLY IS DEFECTIVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24805702 ↗
• MalfunctionApr 4, 2026Inability to Auto-Fill; Pressure Problem

  IT WAS REPORTED BY THE GETINGE FSE THAT DURING ROUTINE CHECKUP THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOFILL ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24785069 ↗
• MalfunctionApr 1, 2026Unintended Power Up; Mechanical Problem

  IT WAS REPORTED BEFORE USE THAT CS100 INTRA AORTIC BALLOON PUMP(IABP) UNIT NOT GETTING SWITCHED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750889 ↗

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-2737-2017 · Jun 16, 2017 · Terminated
  CS 100 Intra-Aortic Balloon Pump
• Z-2736-2017 · Jun 16, 2017 · Terminated
  CS 100i 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.