CS300 Intra-Aortic Balloon Pump, English, 110V 0998-00-3023-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,164 adverse event reports that list this exact device (DI 10607567107882), received between Jun 28, 2019 and Sep 30, 2026 — classified as 12 deaths, 5 injuries, 3,147 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (282 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 3,164 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported by the customer that before use the CS300 Intra-Aortic Balloon Pump (IABP) is leaking helium. No patient involved and no harm is reported. Field Service Engineer (FSE) arrived on site and checked unit over for Audible helium leak. FSE disassembled the unit and checked all internal helium hoses and connections. All were good reassembled checked the connections from the helium regulator out to the helium amount and found after removing the helium tank that the customer had put two seal washers on removed one of them and reinstalled the helium tank and pressurized the system and check for leaks and all is OK. This was user error. FSE has notified customer of correct process per manufacturer requirements.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943369 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported by the customer that prior to use, the CS300 Intra-Aortic Balloon Pump (IABP) had a depleted helium tank. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) evaluated the unit. During the evaluation, the FSE was unable to reproduce the reported issue. The helium level remained constant throughout the service visit. The device subsequently passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942906 ↗
• MalfunctionSep 30, 2026Battery Problem

  It was reported that prior to use the CS300 Intra-Aortic Balloon Pump (IABP) has battery issues. No patient involved and no harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942874 ↗
• MalfunctionSep 30, 2026Noise, Audible

  It was reported that during schedule PM by Getinge FSE the CS300 Intra Aortic Balloon Pump (IABP) compressor making loud rattling noise. There was no patient involvement or adverse event reported. The FSE replaced noisy compressor. All functional and safety checks to meet factory specifications were performed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942855 ↗
• MalfunctionSep 24, 2026Device Contamination with Body Fluid; Unexpected Shutdown

  It was reported by the customer that during clinical use the CS300 Intra-Aortic Balloon Pump (IABP) experienced a blood back. The device shutdown due to blood back during therapy. There was patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that after performing troubleshooting it was verified that the blood entered into unit through a hole in the catheter. The FSE replaced all contaminated parts: tubing, fill manifold assembly, clamp cable, reservoir assembly, condensate removal module, pneumatic connector, purge valve assembly and safety disk. The FSE conducted functional and safety testing. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880612 ↗
• MalfunctionSep 24, 2026Battery Problem

  It was reported that the CS300 Intra-Aortic Balloon Pump (IABP) had a battery failure. There was no patient involvement reported. Battery was replaced. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880098 ↗
• MalfunctionSep 23, 2026Disconnection; Smoking; Sparking; Charging Problem; Material Integrity Problem; Power Problem

  It was reported that during clinical use the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. Battery is not holding a charge and plug malfunction has been reported. Patient involved. Patient was trasffered via air from CFVMC to UNC Hospital for continued care. Furthermore during swapping IABP to teleflex device crew noticed smoking coming from device. Patient successfully swapped to UNC equipment later. After swapping charring on outled was noted. No harm reported. The Getinge FST was dispatched to evaluate the unit. It was reported that FSE plugged the device in and plug started sparking. FSE unplugged device and powered it down. The photos attached during evaluation shows that plug is fried (visible charred plug and deformation).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864383 ↗
• MalfunctionSep 21, 2026Failure to Deflate

  It was reported that prior to use the CS300 Intra-Aortic Balloon Pump (IABP) alarmed low vacuum. No patient involved and no harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836340 ↗
• MalfunctionSep 18, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available

  It was reported by customer that the CS300 Intra-Aortic Balloon Pump (IABP) is not working. It is unknown when the malfunction occurred. There is no information about patient involvement. No harm is reported.Customer stated ¿Broken¿ not definitive failure stated. Tested and examined logs observed numerous ¿Leak in IAB Catheter¿. No patient information or harm reported at time of service visit. Performed all leak tests and passed to specifications. Unit passed all functional and safety tests per factory specifications, returned to customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815057 ↗
• MalfunctionSep 17, 2026No Display/Image

  It was reported that, the CS300 Intra-Aortic Balloon Pump (IABP) screen is not working. It is unknown when malfunction occurred. No patient involved. No harm was reported. Failure observed by end user screen. Tested CS300 and observed on power up distorted screen and vertically not stable. Isolated failure to video cable, returned part. Ordered display conversion kit and installed on pump. Unit passed all functional and safety tests per factory specifications, returned to customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801565 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise

  It was reported by customer that during use, the CS300 Intra-Aortic Balloon Pump (IABP) showing a poor ECG Waveform. Patient involved. No harm was reported. Users swapped out console to continue treatment without issue. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. According to the FSE users surfaced subject unit showing a ¿poor waveform¿ while on Patient. The ¿poor waveform¿ appears to relate to the ECG and/or blood pressure waverforms, however unclear. Other than that, device was fully functional. Users swapped out console to continue treatment without issue. FSE was unable to replicate user complaint but found the ECG trunk cable and leads with significant ruptures on insulation jackets, hence likely related to the ¿poor waveform¿ complaint. Unit calibrated and passed all functional and safety tests per factory specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801562 ↗
• MalfunctionSep 16, 2026Unexpected Shutdown

  It was reported that during a procedure the CS300 Intra-Aortic Balloon Pump (IABP) shutdown. Patient involved and no harm is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785979 ↗
• MalfunctionSep 15, 2026Inflation Problem

  It was reported that prior to use, the CS300 Intra-Aortic Balloon Pump (IABP) did not inflate. No patient involved. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769111 ↗
• MalfunctionSep 14, 2026Increase in Pressure

  It was reported that the CS300 Intra-Aortic Balloon Pump (IABP) had vacuum level and pressure level too high. It is unknown when the malfunction occurred. No patient involved and no harm is reported. Field Service Engineer (FSE) arrived onsite and performed troubleshooting the unit and found that there was no error. Performed preventative maintenance, unit passed off functional test, safety, test, calibration, and returned unit.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752934 ↗
• MalfunctionSep 11, 2026Unexpected Shutdown

  It was reported by the customer that during use the CS300 Intra-Aortic Balloon Pump (IABP) shut off. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that unit shut off and would not turn back on. Plugged unit into AC power, unit came back on and batteries were almost completely depleted after one hour of use. Replaced batteries and charged batteries. Product passed all functional and safety tests per manufacturer specifications. Returned unit to service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727675 ↗
• MalfunctionSep 7, 2026Appropriate Device Problem Term/Code Not Available

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50649830 ↗
• MalfunctionSep 3, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50583083 ↗
• MalfunctionSep 3, 2026Battery Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50579869 ↗
• MalfunctionSep 1, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542216 ↗
• MalfunctionSep 1, 2026Failure to Power Up

  It was reported by the customer that during routine check, the CS300 Intra-Aortic Balloon Pump (IABP) doesn¿t turn on, the monitor turns on for one second and then turns off again. There was no patient involvement. No harm was reported. The FSE reported that the diagnostics were carried out at the Getinge service center. During the diagnostics, a malfunction of the device¿s power supply unit was identified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538740 ↗
• MalfunctionSep 1, 2026Inability to Auto-Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538008 ↗
• MalfunctionAug 30, 2026Appropriate Device Problem Term/Code Not Available; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50514671 ↗
• MalfunctionAug 28, 2026Failure to Calibrate; Battery Problem

  It was reported by the customer that prior to use, the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. Battery maintenance required message was present. There was no patient involvement reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE ran battery test and it failed at 83 minutes. The FSE replaced the defective battery. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497726 ↗
• MalfunctionAug 22, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; Failure to Zero; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50385625 ↗
• MalfunctionAug 20, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50342504 ↗