CS300 Intra-Aortic Balloon Pump, Chinese, 220V 0998-00-3023-45Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, Chinese, 220V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS300 intra-aortic balloon pump has 233 adverse event reports, including 2 injuries and 1 death. The reports mostly describe the pump failing to fill its balloon automatically, air or gas leaks, and error or power messages on startup. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 235
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 10607567108575), received between Oct 12, 2020 and Sep 11, 2026 — classified as 1 death, 2 injuries, 232 malfunctions.
The most frequently reported specific device problem is “Inability to Auto-Fill” (55 reports).
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.
Reports received per month
Most reported problems
Device problems
- Inability to Auto-Fill55
- Gas/Air Leak33
- Appropriate Device Problem Term/Code Not Available32
- Leak/Splash24
- Inflation Problem13
- Failure to Power Up11
- Battery Problem10
- Electrical /Electronic Property Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- Insufficient Information9
- No Patient Involvement4
- No Consequences Or Impact To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cardiac Arrest1
- Cardiogenic Shock1
- Hemodynamic instability1
Recent adverse event reports
The 25 most recent of 235 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Gas/Air Leak
It was reported by the customer that prior to use, the CS300 Intra-Aortic Balloon Pump (IABP) experienced a Leak in IAB Circuit Alarm. There was no patient involvement. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that the safety disk was faulty. After replacement, it passed pre-use inspection. All machine functions and factory-set safety performance metrics were verified, and the unit was approved for clinical use following price negotiation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50727840 ↗MalfunctionSep 2, 2026Inability to Auto-Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566025 ↗MalfunctionAug 11, 2026Inability to Auto-Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208131 ↗MalfunctionAug 6, 2026Inability to Auto-Fill; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50156581 ↗MalfunctionMay 11, 2026Inability to Auto-Fill; Battery Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A BATTERY NEEDS MAINTENANCE MESSAGE AFTER POWER-ON. THE CUSTOMER ALSO REPORTED AN AUTOMATIC INFLATION FAILED MESSAGE. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145322 ↗MalfunctionApr 29, 2026Gas/Air Leak
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE, THE CS300 INTRA AORTIC BALLOON PUMP (IABP) HAD AIR LEAK IN THE IAB LOOP. THERE WAS NO PATIENT HARM AND INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25025615 ↗MalfunctionApr 21, 2026Unexpected Shutdown
IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE INSPECTION THE CS300, CHINESE, NON-UTS INTRA-AORTIC BALLOON PUMP (IABP)DEVICE DISPLAYED A SYSTEM FAILURE ERROR MESSAGE AFTER POWERING ON, ACCOMPANIED BY A BUZZER ALARM. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939351 ↗MalfunctionApr 20, 2026Inability to Auto-Fill
IT WAS REPORTED THAT DURING USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOMATIC INFLATION MALFUNCTION. PATIENT INVOLVEMENT WAS REPORTED, HOWEVER NO PATIENT HARM OR INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24922939 ↗MalfunctionApr 10, 2026Leak/Splash; Battery Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A CIRCUIT LEAK ALARM. THE BALLOON WAS CHECKED AND FOUND TO HAVE NO ABNORMALITIES. PATIENT INVOLVEMENT WAS REPORTED, HOWEVER NO PATIENT HARM OR INJURY OCCURRED, AS THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE TO CONTINUE THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838976 ↗MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE CUSTOMER THAT THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) DEVICE OCCASIONALLY DISPLAYS A MESSAGE MAINTENANCE REQUIRED, CODE 7, WHILE OTHER FUNCTIONS OF THE DEVICE ARE NORMAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796612 ↗MalfunctionMar 30, 2026Restricted Flow rate; Appropriate Device Problem Term/Code Not Available
MalfunctionMar 30, 2026Inability to Auto-Fill; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED AN ALARM LOOP LEAK INDICATING AUTOMATIC INFLATION FAILURE. . THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24711652 ↗MalfunctionMar 6, 2026Gas/Air Leak
IT WAS REPORTED BY CUSTOMER THAT DURING ROUTINE MAINTENANCE, THE CS300 INTRA AORTIC BALLOON PUMP HAD A LEAK IN IAB CIRCUIT ALARM DUE TO A LEAKING SAFETY DISC. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528553 ↗MalfunctionMar 2, 2026Gas/Air Leak
IT WAS REPORTED BY THE CUSTOMER THAT DURING MAINTENANCE AN ERROR WAS FOUND AFTER POWERING ON THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) MACHINE: LOOP LEAK. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24479929 ↗MalfunctionFeb 18, 2026Inability to Auto-Fill
IT WAS REPORTED BY THE CUSTOMER THAT DURING PRE-USE SELF TEST THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) EQUIPMENT ALARMED AND FAILED TO AUTOMATICALLY INFLATE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376086 ↗MalfunctionFeb 18, 2026Inability to Auto-Fill
MalfunctionFeb 17, 2026Gas/Air Leak
IT WAS REPORTED BY THE CUSTOMER THAT DURING A ROUTINE INSPECTION, AN AIR LEAK WAS FOUND IN THE ALARM LOOP OF THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) DEVICE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369256 ↗MalfunctionFeb 16, 2026Decrease in Pressure
IT WAS REPORTED BY CUSTOMER THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD ALARMED DUE TO LOW NEGATIVE PRESSURE DURING USE. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342048 ↗MalfunctionFeb 12, 2026Moisture or Humidity Problem; Noise, Audible
IT WAS REPORTED DURING PRE-USE CHECK INSPECTION THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A CONDENSER MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320261 ↗MalfunctionFeb 11, 2026Inability to Auto-Fill; Gas/Air Leak
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE THE CS300 IABP HAD AN AUTOMATIC INFLATION MALFUNCTION AND THE DRIVE VALVE ASSEMBLY TEST FAILED. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311781 ↗MalfunctionFeb 5, 2026Battery Problem
MalfunctionFeb 3, 2026Inability to Auto-Fill; Gas/Air Leak
MalfunctionFeb 3, 2026Inability to Auto-Fill
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED AN ERROR MESSAGE THAT AUTOMATIC INFLATION FAILED DURING TESTING, RENDERING THE DEVICE UNUSABLE. THERE WERE NO PATIENTS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243856 ↗MalfunctionFeb 3, 2026Leak/Splash; Pressure Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE INSPECTION THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) SYSTEM'S SELF-TEST REVEALED AN EXCESSIVELY LOW POSITIVE MOTOR PRESSURE, CAUSING THE VALVE ASSEMBLY LEAKAGE TEST TO FAIL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243592 ↗MalfunctionJan 30, 2026Inability to Auto-Fill
Other System, Balloon, Intra-Aortic And Control devices
- CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53Datascope Corp. · System, Balloon, Intra-Aortic And Control21 recalls39 deaths10,316 reports
- CS300 Intra-Aortic Balloon Pump, English, 110V 0998-00-3023-53Datascope Corp. · System, Balloon, Intra-Aortic And Control12 deaths3,164 reports
- CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls8 deaths1,686 reports
- CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls5 deaths1,181 reports
- CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52Datascope Corp. · System, Balloon, Intra-Aortic And Control19 recalls2 deaths1,157 reports
- SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01Datascope Corp. · System, Balloon, Intra-Aortic And Control2 recalls33 deaths1,541 reports
- CARDIOSAVE RESCUE 0998-00-0800-83Datascope Corp. · System, Balloon, Intra-Aortic And Control26 recalls167 reports
- CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls3 deaths456 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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