CS300 Intra-Aortic Balloon Pump, French, 110V 0998-00-3023-62Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10607567108292), received between Mar 17, 2021 and Nov 19, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Insufficient Device Problem Information; Noise, Audible; Insufficient Device Problem Information; Noise, Audible

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SCREEN CRACKLING DURING TURNING ON. NO PATIENT DAMAGE WAS REPORTED.

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

  MAUDE report 20724489 ↗
• MalfunctionMay 8, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  N/A

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

  MAUDE report 19271020 ↗
• MalfunctionApr 3, 2023Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAS A BATTERY MALFUNCTION THE UNIT SWITCHES OFF WHEN UNPLUGGED FROM THE MAINS.

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

  MAUDE report 16667625 ↗
• MalfunctionMar 28, 2023Inadequate User Interface; Inadequate User Interface

  N/A.

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

  MAUDE report 16626623 ↗
• MalfunctionDec 28, 2022Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A BALLOON BROKE DURING USE ON A PATIENT CAUSING BLOOD TO GO INSIDE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP).

  Patient problems: Insufficient Information

  MAUDE report 16062274 ↗
• MalfunctionApr 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A REPAIR EVALUATION FOR A PRIOR REPAIR CALL BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A LEAK THAT WAS NOTICED ON THE DRIVE MANIFOLD. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254358 ↗
• MalfunctionFeb 15, 2022Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD BLOOD BACKED ALL THE WAY THROUGH THE TUBING AND POTENTIALLY INTO THE MACHINE. THERE WAS NO PATIENT HARM AND NO ADVERSE EVENT WAS REPORTED.

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

  MAUDE report 13536784 ↗
• MalfunctionFeb 8, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) GAVE AN ALARM AND A MESSAGE. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481363 ↗
• MalfunctionJul 15, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172294 ↗
• MalfunctionJun 30, 2021Unexpected Shutdown; Unexpected Shutdown

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092776 ↗
• MalfunctionJun 21, 2021Unexpected Shutdown; Unexpected Shutdown

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032271 ↗
• MalfunctionApr 26, 2021Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD BLURRY LINES ON THE DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726737 ↗
• MalfunctionMar 17, 2021Power Problem; Power Problem

  IT WAS REPORTED BY THE CUSTOMER'S BIOMED THAT DURING USE ON A PATIENT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS ON BATTERIES AND WHEN SWITCHED OFF, THERE WAS NO AC POWER. SUBSEQUENTLY, THE USER SWITCHED OFF AND ON THE AC POWER AND AFTER THAT THE MACHINE SWITCHED ON DIRECTLY. THERE WAS NO HARM OR INJURY TO PATIENT AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506907 ↗