CS300 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INT'L 0998-UC-3023-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10607567108728), received between Mar 2, 2022 and Jan 28, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Power Problem; Power Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249684 ↗
• MalfunctionOct 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY MALFUNCTIONED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536195 ↗
• MalfunctionAug 22, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUTDOWN UNEXPECTEDLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027373 ↗
• MalfunctionJun 28, 2024Inability to Auto-Fill; Inability to Auto-Fill

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636361 ↗
• MalfunctionApr 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A.

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

  MAUDE report 19179750 ↗
• MalfunctionSep 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN ELECTRICAL TEST FAIL CODE 50. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783059 ↗
• MalfunctionDec 29, 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) UNITS BATTERIES ARE WITHOUT AUTONOMY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072770 ↗
• MalfunctionMar 30, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DISTORTED ECG / PRESSURE SIGNAL. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF A PATIENT WAS INVOLVED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955984 ↗
• MalfunctionMar 2, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN AFTER 45 MINUTES OF USE. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656410 ↗