CS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,NON-UTS,INT'L 0998-UC-3023-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10607567108759), received between Apr 29, 2022 and Apr 28, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Device Sensing Problem; Device Sensing Problem

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916484 ↗
• MalfunctionFeb 18, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD PRESSURE TRANSDUCER DRIVE MANIFOLD PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398089 ↗
• MalfunctionJan 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT BEFORE USE, CS300 INTRA AORTIC BALLOON PUMP (IABP) SCREEN DID NOT TURN ON PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270792 ↗
• MalfunctionDec 21, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A ROUTINE CHECK BY THE USER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAS A BLACK SCREEN AND DOES NOT WORK. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 18372688 ↗
• MalfunctionOct 13, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT DURING ROUTINE TESTING, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT DOES NOT DETECT MAINS VOLTAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935123 ↗
• MalfunctionOct 10, 2023Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECK THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS FIBER OPTIC DOES NOT WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

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

  MAUDE report 17906708 ↗
• MalfunctionApr 29, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BATTERY CHANGE. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF A PATIENT WAS INVOLVED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. CAMBIO DE BATERIAS. EL CLIENTE NO APORTA MAS INFORMACION CS300 **CESION. THIS IS AN AUTOMATED DRAFT TRANSLATION - IF ANY UNCERTAINTY CONTACT THE LOCAL SSU IMMEDIATELY: BATTERY CHANGE * THE CLIENT DOES NOT PROVIDE MORE INFORMATION CS300 **ASSIGNMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251739 ↗