CS300 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,UTS,DOM 0998-UC-3023-83Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10607567108711), received between Feb 25, 2021 and Aug 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Failure to Power Up

  It was reported by the customer that during routine check, the CS300 Intra-Aortic Balloon Pump (IABP) is not turning on. No patient involved. No harm was reported. FSE Replaced power supply which resolved issue. FSE completed repair successfully. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446874 ↗
• MalfunctionAug 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EXHIBITED SCREEN FLICKERING, WITH FLASHING LINES VISIBLE ON THE DISPLAY. NO PATIENT WAS INVOLVED OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747257 ↗
• MalfunctionFeb 5, 2025Unexpected Shutdown; Unexpected Shutdown

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311687 ↗
• MalfunctionJan 8, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAS BATTERY CHARGING ISSUES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100277 ↗
• MalfunctionAug 22, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED BATTERY RUN TIME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15269150 ↗
• MalfunctionSep 9, 2021Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) COULD NOT OBTAIN THE ECG TRACING. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449426 ↗
• MalfunctionMar 30, 2021Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591115 ↗
• MalfunctionFeb 25, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) POWERED DOWN ON ITS OWN, WHILE PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11381186 ↗