CS100 Intra-Aortic Balloon Pump, Japanese, 110V 0998-00-3013-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10607567107684), received between Sep 25, 2020 and Mar 19, 2026 — classified as 1 death, 59 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2218-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Device Contamination with Body Fluid

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637040 ↗
• MalfunctionMar 6, 2026Decrease in Pressure

  IT WAS REPORTED THAT THE CS100 INTRA AORTIC BALLOON PUMP (IABP) EXPERIENCED AN ISSUE OF INSUFFICIENT COMPRESSOR NEGATIVE PRESSURE. THE EVENT WAS IDENTIFIED DURING OPERATION OF THE DEVICE. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530482 ↗
• MalfunctionDec 14, 2025Gas/Air Leak; Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798894 ↗
• MalfunctionAug 19, 2025Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE INSPECTION, CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837550 ↗
• MalfunctionAug 7, 2025No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  IT WAS REPORTED BY THE CUSTOMER THAT BEFORE USE ON A PATIENT CS100 INTRA-AORTIC BALLOON PUMP (IABP) WHEN THE POWER WAS TURNED ON, A SCREEN DISPLAY FAILURE (NOISE) OCCURRED. NO PATIENT HARM AND INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735319 ↗
• MalfunctionJun 23, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD STOPPED UNINTENTIONALLY. NO HARM OR INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308930 ↗
• MalfunctionJun 5, 2025Gas/Air Leak; Infusion or Flow Problem; Gas/Air Leak; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD RAPID GAS LEAK ALARM. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148803 ↗
• MalfunctionMay 15, 2025Gas/Air Leak; Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026690 ↗
• MalfunctionMar 3, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED IMMEDIATELY AFTER THE START OF CLINICAL USE THAT CS100 INTRA-AORTIC BALLOON PUMP SAID OPTICAL SENSOR CALIBRATION NOT POSSIBLE. NO HARM OR INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21505464 ↗
• MalfunctionMar 3, 2025Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED BY THE CUSTOMER THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTO-FILL ERROR DURING USER CHECKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503086 ↗
• MalfunctionJan 20, 2025Failure to Charge; Charging Problem; Failure to Charge; Charging Problem

  IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) CANNOT BE CHARGED.

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

  MAUDE report 21190446 ↗
• MalfunctionDec 13, 2024Inability to Auto-Fill; Electrical /Electronic Property Problem; Inability to Auto-Fill; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD FREQUENT AUTOMATIC REFILL ERRORS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929836 ↗
• MalfunctionNov 19, 2024Failure to Power Up; Failure to Power Up

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724358 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT DURING CUSTOMER INSPECTION, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S TWO REAR CART CASTERS ARE BROKEN. THERE WAS NO PATIENTS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19679709 ↗
• MalfunctionJun 14, 2024Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536214 ↗
• MalfunctionJun 3, 2024Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446968 ↗
• MalfunctionApr 16, 2024Appropriate 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) THERE WAS NO ARTERIAL WAVEFORM ON DISPLAY. OPERATED WITH ECG TRIGGER AND TRANSPORTED TO MIE UNIVERSITY HOSPITAL. TRANSFERRED TO CARDIOSAVE AT MIE UNIVERSITY HOSPITAL. THE CARDIOSAVE DISPLAYED ARTERIAL PRESSURE WAVEFORM AND FUNCTIONED NORMALLY. THERE WAS NO HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115245 ↗
• MalfunctionDec 29, 2023Output Problem; Output Problem

  N/A

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

  MAUDE report 18419264 ↗
• MalfunctionDec 19, 2023Gas/Air Leak; Gas/Air Leak

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357194 ↗
• MalfunctionDec 6, 2023Positioning Problem; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275236 ↗
• MalfunctionNov 9, 2023Appropriate 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 18104339 ↗
• MalfunctionNov 2, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD ABNORMAL NOISE DUE TO FAN ABNORMALITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057448 ↗
• MalfunctionNov 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING AN INSPECTION THE CS100 INTRA-AORTIC BALLOON PUMP (IABP)CASTER IS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049361 ↗
• MalfunctionOct 31, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040103 ↗
• MalfunctionOct 25, 2023Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007625 ↗

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-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.