CS100 Intra-Aortic Balloon Pump, Refurbished, JAPANESE,NON-UTS,DOM 0998-UC-3013-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10607567108674), received between Sep 23, 2020 and Nov 12, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT, BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREEN DISPLAY PROBLEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662413 ↗
• MalfunctionApr 30, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT NEEDS A CART WHEEL REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217296 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT DURING REGULAR INSPECTION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS CASTER DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551976 ↗
• MalfunctionOct 17, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING TRANSPORTATION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY STOPPED WORKING AFTER ABOUT 5 MINUTES . IT WAS USED IN CONJUNCTION WITH ECMO AND CURRENTLY IN CONTINUOUS USE WITH AC DRIVE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951517 ↗
• MalfunctionJul 27, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN BECOMES A SANDSTORM DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406999 ↗
• MalfunctionJun 21, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING START UP, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN S BLACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170533 ↗
• MalfunctionAug 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT INFLATING THE BALLOON. HOWEVER THE ISSUE WAS CONFIRMED WHEN THE BALLOON WAS ABLE TO EXPAND OUTSIDE THE BODY. THE USER REPLACED THE CATHETER FOR AND A NEW TRP3546 WAS INSERTED USING A DIFFERENT IABP AS WELL. THE USER STATED, THAT WHEN THE DIFFERENT CS100 WAS USE, THE BALLOON EXPANSION FAILURE WAS RESOLVED. 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 12258211 ↗
• MalfunctionDec 24, 2020Erratic or Intermittent Display; No Display/Image; Display or Visual Feedback Problem; Erratic or Intermittent Display; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY BLACKED OUT. AFTER STARTING BACK UP, THE DISPLAY BECAME DISTORTED AND COULD NOT BE USED. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11072204 ↗
• MalfunctionDec 15, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A CARDIAC SURGICAL PROCEDURE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) SHUTDOWN. IT WAS ALSO REPORTED THAT THE USER RESTARTED THE UNIT AND WAS ABLE TO USE IT SAFELY. FURTHER, THE MACHINE WAS CHANGED AT 15:00 HOURS TO SEE WHAT WAS IMPORTANT. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11008023 ↗
• MalfunctionNov 17, 2020No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DID NOT POWER UP. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10855488 ↗
• MalfunctionSep 23, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT UPON POWER UP AND PRIOR TO USE, THE DISPLAY FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT VISIBLE. THE END USER RESTARTED THE POWER SUPPLY THREE (3) TIMES BUT THE CONDITIONS DID NOT IMPROVE. IT WAS NOTED THAT AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS COMPLETED, THE IABP UNIT WAS POWERED ON AGAIN AND THE IABP UNIT DISPLAY DID NOT HAVE ANY ISSUES. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10573288 ↗

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.