CS100 Intra-Aortic Balloon Pump, Refurbished, CHINESE,NON-UTS,INTL 0998-UC-3013-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10607567111957), received between Sep 28, 2020 and Jul 17, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT DISPLAYS FAULT CODE #53. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333921 ↗
• MalfunctionDec 20, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A LOOP AIR LEAKAGE FAULT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014087 ↗
• InjuryAug 12, 2021Device Emits Odor; Appropriate Device Problem Term/Code Not Available; Device Emits Odor; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: Nausea

  MAUDE report 12312883 ↗
• MalfunctionAug 10, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300257 ↗
• MalfunctionAug 3, 2021Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) ALARMED "LEAK IN IAB CIRCUIT". NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267412 ↗
• MalfunctionMay 11, 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 11808822 ↗
• MalfunctionJan 22, 2021Gas/Air Leak; Gas/Air Leak

  N/A.

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

  MAUDE report 11215976 ↗
• MalfunctionDec 23, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED BY THE DISTRIBUTOR THAT PRIOR TO USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNEXPECTEDLY SHUTDOWN AFTER THE UNIT WAS TURNED ON FOR LESS THAN ONE MINUTE. IT WAS ALSO REPORTED THAT THE CUSTOMER CHECKED TO ENSURE THAT THE POWER SUPPLY WAS CONNECTED AND ATTEMPTED TO RESTART THE UNIT. HOWEVER, THE REPORTED ISSUE PERSISTED AND THE CUSTOMER SWITCHED TO ANOTHER IABP UNIT. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11067125 ↗
• MalfunctionDec 11, 2020Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION AND TESTING OF THE CS100 INTRA-AORTIC BALLOON PUMP (IABP), THE UNIT ALARMED AN ISSUE OF "NEGATIVE PRESSURE TO LOW." THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10993753 ↗
• MalfunctionNov 18, 2020Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A NEGATIVE PRESSURE TOO LOW MESSAGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10863339 ↗
• MalfunctionNov 5, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DAY AFTER THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS INSTALLED AN ERROR CODE # 50 FOR THE ELECTRICAL SAFETY TEST FAILURE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10792651 ↗
• MalfunctionOct 28, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOMATIC INFLATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10749892 ↗
• MalfunctionSep 28, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT BEFORE USE THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) AUTOMATICALLY SHUT DOWN AFTER THE INTERVENTIONAL CATHETERIZATION ROOM NURSE TURNED IT ON AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10592484 ↗

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-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-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-2736-2017 · Jun 16, 2017 · Terminated
  CS 100i Intra-Aortic Balloon Pump
• Z-2737-2017 · Jun 16, 2017 · Terminated
  CS 100 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.