CS100 Intra-Aortic Balloon Pump, French, 220V 0998-00-3013-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10607567107509), received between Jan 15, 2021 and Mar 31, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K031636); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Battery Problem; Gas/Air Leak

  IT WAS REPORTED DURING ROUTINE CHECK BY CUSTOMER THE CS100 HAD MESSAGE ABOUT A SECURITY DISK LEAK AND BATTERY MAINTENANCE TO BE PERFORMED. NO PATIENT WAS INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739860 ↗
• MalfunctionFeb 14, 2026Failure to Read Input Signal

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340527 ↗
• MalfunctionFeb 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD A POWER CABLE CUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341683 ↗
• MalfunctionNov 15, 2024Incomplete or Missing Packaging; Appropriate Device Problem Term/Code Not Available; Incomplete or Missing Packaging; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) LOANER ECG CABLE WAS MISSING.

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

  MAUDE report 20694069 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DAMAGED ECG CABLE.

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

  MAUDE report 19928382 ↗
• MalfunctionJul 5, 2024Erratic or Intermittent Display; Connection Problem; Erratic or Intermittent Display; Connection Problem

  IT WAS REPORTED AFTER USE THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN TURNED WHITE FOLLOWING A SHOCK. THE COMPLAINANT FOLDED THE SCREEN DOWN ONTO THE CABLES, THE SHOCK OCCURRED AT THE THE END OF THE PROCEDURE WHEN IT WAS TIME TO PUT AWAY THE EQUIPMENT. NO PATIENT INVOLVEMENT OR NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680373 ↗
• MalfunctionDec 22, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S BLOOD DETECTION CELL WAS DEFECTIVE AND REQUIRED REPLACEMENT. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 18384556 ↗
• MalfunctionDec 19, 2023Failure to Power Up; Failure to Power Up

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355896 ↗
• MalfunctionOct 30, 2023Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING START UP, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A SCREEN PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034432 ↗
• MalfunctionSep 28, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD SCREEN PROBLEM.

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

  MAUDE report 17835427 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN IV POLE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249004 ↗
• MalfunctionAug 12, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS NOT WORKING PROPERLY. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF THERE WAS ANY PATIENT INVOLVEMENT.

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

  MAUDE report 15218397 ↗
• MalfunctionAug 4, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DISPLAY FAILURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164511 ↗
• MalfunctionOct 21, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673693 ↗
• MalfunctionMar 30, 2021Display Difficult to Read; Display Difficult to Read

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589949 ↗
• MalfunctionJan 15, 2021No Display/Image

  IT WAS REPORTED THAT DURING A SELF-TEST, THE DISPLAY OF THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS UNREADABLE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11178624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031636. One submission often covers many models, so check the product and lot details in each record.

• Z-1486-2026 · Jan 23, 2026 · Open, Classified
  CS100 IABP. Software Version CS100 IABP Q.01.
• Z-3085-2017 · Jul 17, 2017 · Open, Classified
  CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by a
• Z-3086-2017 · Jul 17, 2017 · Open, Classified
  CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by au
• Z-2737-2017 · Jun 16, 2017 · Terminated
  CS 100 Intra-Aortic Balloon Pump
• Z-2736-2017 · Jun 16, 2017 · Terminated
  CS 100i Intra-Aortic Balloon Pump
• Z-1523-2014 · Mar 21, 2014 · Terminated
  Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate in
• Z-2414-2011 · Mar 16, 2011 · Terminated
  Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 130
• Z-1811-2010 · May 10, 2010 · Terminated
  CS100 Intra-Aortic Balloon Pump.