CS100 Intra-Aortic Balloon Pump, Chinese, 220V 0998-00-3013-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 684 adverse event reports that list this exact device (DI 10607567107790), received between Dec 31, 2019 and Sep 30, 2026 — classified as 2 deaths, 1 injury, 681 malfunctions.

The most frequently reported specific device problem is “Inability to Auto-Fill” (123 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 25 most recent of 684 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Insufficient Device Problem Information

  The hospital reports that the machine may have caused the patient's death. They are currently closely monitoring the situation and checking the machine's operation.

  Patient problems: Insufficient Information

  MAUDE report 50942560 ↗
• MalfunctionSep 29, 2026Inability to Auto-Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931387 ↗
• MalfunctionSep 18, 2026Material Integrity Problem

  It was reported that during pre-use testing, the CS100 Intra-Aortic Balloon Pump (IABP) safety disk could not be secured. Date of event is unknown. No patient involvement. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that guide block securing the safety disk was broken and detached. Guide block was replaced. Product passed all functional and safety tests per manufacturer specifications. The equipment has been delivered to the customer and is ready for clinical use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813852 ↗
• MalfunctionSep 16, 2026Power Problem

  It was reported by customer that during routine check the CS100 Intra-Aortic Balloon Pump (IABP) has backup battery run out of power. No patient involved and no harm is reported. The battery life has run out; all other functions are working normally, but the hospital is not considering a replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785338 ↗
• MalfunctionSep 15, 2026Inability to Auto-Fill

  It was reported by the customer that during use, the CS100 Intra-Aortic Balloon Pump (IABP) malfunctioned. Unit displayed Autofill Failure Alarm. User replaced the unit with another one. Patient was involved. There was no patient harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the fault was caused by insufficient negative pressure leading to an automatic inflation failure, requiring the replacement of the 5000-hour maintenance kit. Parts were replaced. Product passed all functional and safety tests per manufacturer specifications. Unit was delivered to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770753 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise

  It was reported by the customer that during use, the CS100 Intra-Aortic Balloon Pump (IABP) had poor ECG signal when using the device. There was patient involvement. No harm was reported. Customer switched to another device The Field Service Engineer reported that after replacing the ECG lead wires, the equipment functioned normally. Product passed all functional and safety tests per manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727837 ↗
• MalfunctionSep 7, 2026Battery Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50645193 ↗
• MalfunctionSep 3, 2026Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50588174 ↗
• MalfunctionAug 30, 2026Erratic or Intermittent Display

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50514669 ↗
• MalfunctionAug 14, 2026Unexpected Shutdown

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252576 ↗
• MalfunctionAug 10, 2026Inability to Auto-Fill; Mechanical Problem; Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192501 ↗
• MalfunctionMay 16, 2026Gas/Air Leak

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE, THE CS100 INTRA AORTIC BALLOON PUMP (IABP) DISPLAYED AN IAB CIRCUIT GAS LEAK ALARM. PATIENT INVOLVEMENT WAS REPORTED, HOWEVER NO PATIENT HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195218 ↗
• MalfunctionMay 14, 2026Display or Visual Feedback Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) MALFUNCTIONED BEFORE USE. THE DEVICE OCCASIONALLY DISPLAYS A DISTORTED SCREEN WHEN POWERED ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169634 ↗
• MalfunctionMay 12, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT DURING POWER-ON TESTING, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED ERROR CODE 5. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148306 ↗
• MalfunctionMay 12, 2026Inability to Auto-Fill; Gas/Air Leak

  IT WAS REPORTED DURING A ROUTINE INSPECTION THAT CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD AUTOFILL FAILURE ALARM AND DRIVE MANIFOLD TEST FAILURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147583 ↗
• MalfunctionMay 12, 2026Inability to Auto-Fill; Inflation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE CS100 INTRA AORTIC BALLOON PUMP(IABP) HAD AUTOMATIC INFLATION FAILURE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146106 ↗
• MalfunctionMay 8, 2026Device Dislodged or Dislocated; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PRE USE CHECK CS100 INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED CATHETER DISLODGEMENT ALONG WITH DETACHMENT OF THE TUBING AND THE DEVICE WAS UNUSABLE. FOLLOWING REPAIR A LEAK WAS IDENTIFIED IN THE IABP SAFETY DISC AND REPLACEMENT OF THE SAFETY DISC WAS RECOMMENDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122501 ↗
• MalfunctionMay 7, 2026Power Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DRUING RUTINE TESTING THE CS100 INTRA AORTIC BALLOON PUMP (IABP) MALFUNCTIONED. NURSES FOUND DURING ROUTINE TESTING OF THE EQUIPMENT THAT THE MONITOR FLICKERED BRIEFLY AND THEN WENT BLACK, PREVENTING THE EQUIPMENT FROM POWERING ON. THE POWER SUPPLY MODULE FAILED, AND A PRELIMINARY QUOTE WAS GIVEN TO THE CUSTOMER. HOWEVER, DUE TO THE HIGH PRICE AND THE AGE OF THE EQUIPMENT, THE CUSTOMER DECIDED TO ABANDON THE REPAIR AND SCRAP THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112600 ↗
• MalfunctionApr 29, 2026Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035120 ↗
• MalfunctionApr 28, 2026Unexpected Shutdown

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011072 ↗
• MalfunctionApr 22, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING MAINTENANCE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DRIVE VALVE ASSEMBLY TEST FAILED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950230 ↗
• MalfunctionApr 20, 2026Gas/Air Leak

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN ALARM FOR EXCESSIVELY LOW NEGATIVE PRESSURE. PATIENT INVOLVED AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924957 ↗
• MalfunctionApr 13, 2026Decrease in Pressure; Gas/Air Leak

  IT WAS REPORTED THAT DURING PRE USE TESTING, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) MALFUNCTIONED. NEGATIVE PRESSURE WAS REPORTED TOO LOW. THERE WAS NO PATIENT INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858040 ↗
• MalfunctionApr 13, 2026Device Alarm System

  IT WAS REPORTED BY CUSTOMER THAT THE CS100 HAD DEVICE DISPLAYED A CATHETER CONNECTION DETACHMENT WARNING, BUT CONTINUED OPERATION AFTER PRESSING THE START BUTTON, WITHOUT CAUSING ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853836 ↗
• MalfunctionApr 13, 2026Inflation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE CS100 HAD INFLATION MALFUNCTION DURING EQUIPMENT USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853784 ↗

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.