CS300 Intra-Aortic Balloon Pump, Spanish, 110V 0998-00-3023-57Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10607567108254), received between Nov 17, 2020 and May 19, 2025 — classified as 2 deaths, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Inability to Auto-Fill” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Inability to Auto-Fill; Unexpected Shutdown; Inability to Auto-Fill; Unexpected Shutdown

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP HAS BEEN SHUT DOWN BUT HAS NOT PROVIDED FURTHER INFORMATION. HOWEVER, THE TECHNICAL INSPECTION INDICATES THAT THE EQUIPMENT HAS ALREADY REACHED 5,000 HOURS OF EFFECTIVE USE (CURRENTLY 16,388.8 HOURS). THIS INDICATES THAT THE 5,000-HOUR ENGINE REBUILD KIT MUST BE REPLACED, AS INDICATED BY THE MANUFACTURER, TO ENSURE THE PROPER VACUUM AND PRESSURE SUPPLY THAT THE ENGINE SHOULD PROVIDE. THERE IS NO EVIDENCE OF ACTUAL OR POTENTIAL DAMAGE OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042801 ↗
• DeathMay 16, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN DURING THE PATIENT'S TRANSFER FROM THE CORONARY ICU TO THE CT SCAN. EVENT OCCURRED ON (B)(6) 2025, 4:30 PM. THE PATIENT DIED, ALTHOUGH IT IS UNKNOWN IF IT WAS DUE TO THE EQUIPMENT.

  Patient problems: Insufficient Information

  MAUDE report 22033332 ↗
• MalfunctionOct 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING CORRECTIVE MAINTENANCE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SHOWED ERROR CODE 91 WHEN THE PC BOARD WAS REPLACED AND THE PC BOARD IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535009 ↗
• MalfunctionJul 24, 2024Inability to Auto-Fill; Battery Problem; Appropriate Device Problem Term/Code Not Available; Inability to Auto-Fill; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A RECURRING AUTO-FILLING FAILURE. EVENT # 1: DURING THE SHIFT HANDOVER, THE BCIA CONSOLE ASSIGNED TO SURGERY THROWS THE AUTO-FILLING FAILURE ALARM, DESPITE THE SAME ALARM BEING ACTIVATED, THE BALLOON DOES NOT WORK, WHICH IS WHY A CARDIOVASCULAR CONSOLE MUST BE REQUESTED AND THE INCIDENT IS REPORTED IN THE OPERATING ROOMS EVENT # 2: THE CONSOLE THROWS AN ALARM FOR BATTERY MAINTENANCE IN THE MORNING, WHICH IS REPORTED, AROUND NOON IT THROWS AN AUTO-FILLING FAILURE AND DESPITE STOPPING, ZEROING AND GIVING ASSISTANCE, IT DOES NOT SELF-FILL, STOPPING COUNTERPULSATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821313 ↗
• InjuryJun 7, 2023Premature Discharge of Battery; Power Problem; Appropriate Device Problem Term/Code Not Available; Premature Discharge of Battery; Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE ON PATIENT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EQUIPMENT DISPLAYS AN ALARM DUE TO POWER DISCONNECTION AND DOES NOT RECORD IT IN THE ERROR LOG , PATIENT WAS ADMITTED TO THE HEMODYNAMIC ROOMS WITH POP ANGIOPLASTY OF THE ANTERIOR DESCENDING ARTERY DUE TO ACUTE MYOCARDIAL INFARCTION WITH ST SEGMENT ELEVATION. AT THE TIME OF THE TRANSFER THE BALLOON CONTROL CONSOLE RAN OUT OF BATTERY WHEN ENTERED IN THE INTENSIVE CARE UNIT. THE CONSOLE WAS CONNECTED DURING THE ENTIRE PROCEDURE WHICH TAKEN APPROXIMATELY ONE HOUR AND TWENTY MINUTES BEFORE LEAVING THE ROOM, THE BATTERY CHARGE OF THE CONSOLE WAS CHECKED WHICH WAS ABOVE SEVENTY PERCENT. THE PROCEDURE IS CARRIED OUT SUCCESSFULLY. WHEN TURNING THE CONSOLE OFF N THE INTENSIVE CARE UNIT , THE PATIENT TAKES LESS THAN ONE MINUTE WITHOUT ASSISTANCE AND HOWEVER HEMODYNAMICALLY UNSTABLE PATIENT , ENTERS CARDIORESPIRATORY ARREST, RESUSCITATION MANEUVERS ARE PERFORMED AND PATIENT IS RETURNED TO CIRCULATION AFTER TWO MINUTES OF RESUSCITATION.

  Patient problems: Cardiac Arrest; Insufficient Information; Myocardial Infarction

  MAUDE report 17077492 ↗
• MalfunctionOct 29, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721685 ↗
• DeathOct 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Arrest

  MAUDE report 12623943 ↗
• MalfunctionApr 6, 2021Battery Problem; Unexpected Shutdown; Battery Problem; Unexpected Shutdown

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619378 ↗
• MalfunctionMar 26, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574013 ↗
• MalfunctionDec 8, 2020Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED DURING PREVENTATIVE MAINTENANCE THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10971484 ↗
• MalfunctionNov 18, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) THE BATTERY CHARGE WOULD NOT LAST LONG ENOUGH. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10860539 ↗
• MalfunctionNov 17, 2020Inability to Auto-Fill; Pressure Problem; Inability to Auto-Fill; Pressure Problem

  IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DRIVE MANIFOLD ISSUE. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10851854 ↗