CS300 Intra-Aortic Balloon Pump, Refurbished, JAPANESE,NON-UTS,DOM 0998-UC-3023-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10607567108803), received between Feb 28, 2023 and Sep 18, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082668 ↗
• MalfunctionJul 31, 2025Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE CUSTOMER, DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN WENT BLACK ONCE. AFTER RESTARTING THE DEVICE, THE SCREEN BEGAN TO FLICKER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675248 ↗
• MalfunctionOct 29, 2024Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555317 ↗
• MalfunctionJul 25, 2024Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831810 ↗
• MalfunctionJul 3, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WILL NOT CHARGE.PATIENT INVOLVED AND NO HARM REPORTED.

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

  MAUDE report 19665979 ↗
• MalfunctionJun 7, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT  THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A MALFUNCTION OF THE ARTERIAL PRESSURE  CONNECTOR. THEY RECEIVED A MESSAGE SAYING THAT THE CONNECTION WAS UNSTABLE AND IT COULD NOT BE USED NORMALLY. THE ARTERIAL PRESSURE CABLE CONNECTOR WAS RE-CONNECTED TO THE PRESSURE INPUT OF THE IABP AND THE ISSUE WAS RESOLVED. IABP THERAPY WAS CONTINUED WITH THIS IABP UNIT WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORTED INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482624 ↗
• MalfunctionMay 21, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS ARTERIAL PRESSURE SIGNAL MAY BE INTERRUPTED. THERE WAS NO PATIENT HARM REPORTED.

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

  MAUDE report 19364699 ↗
• MalfunctionMar 15, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN DISPLAY BECAME COMPLETELY WHITE. THERE WAS NO HEALTH HAZARD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913587 ↗
• MalfunctionDec 27, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS POOR SCREEN DISPLAY. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401421 ↗
• MalfunctionDec 19, 2023No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357080 ↗
• MalfunctionSep 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Fitting Problem; Device Contamination with Body Fluid; Incorrect, Inadequate or Imprecise Result or Readings; Fitting Problem; Device Contamination with Body Fluid

  IT WAS REPORTED THAT WHEN THE MACHINE WAS BROUGHT INTO THE COMPANY AND DURING A REGULAR INSPECTION PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) COULD NOT BE FIXED TO THE TRANSPORT CART, THE ELECTRICAL TEST FAILS CODE #50 HAD OCCURRED, AND BLOOD HAD INTRUDED INTO THE IABP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671317 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING REGULAR INSPECTION PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (GFSE), THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN FIBER CONNECTOR PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548769 ↗
• MalfunctionJul 19, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A BATTERY ISSUE AND WHEN THE AC POWER CORD IS PULLED OUT, THE POWER IS TURNED OFF. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 17351164 ↗
• MalfunctionJun 28, 2023No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT BEFORE USE , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A DEFECTIVE SCREEN DISPLAY SHOWING SCREEN DISPLAY SANDSTORM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221774 ↗
• MalfunctionFeb 28, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) IF UNITS NEGATIVE PRESSURE OF THE COMPRESSOR IS INSUFFICIENT ALARM OCCURS MULTIPLE TIMES. THERE WAS NO HEALTH DAMAGE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456138 ↗