CS300 Intra-Aortic Balloon Pump, Japanese, 110V 0998-00-3023-65Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, Japanese, 110V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS300 intra-aortic balloon pump has 323 reports, including 3 injuries and 3 deaths. Many describe gas leaks, screen and display problems, sensing failures, and automatic filling errors. No recalls name this device. Reports fell to 18 in the last 12 months from 88 in the 12 months before.
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
- 326
- Deaths reported
- 3
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 326 adverse event reports that list this exact device (DI 10607567108322), received between Aug 28, 2020 and Sep 23, 2026 — classified as 3 deaths, 3 injuries, 320 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (36 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
- Appropriate Device Problem Term/Code Not Available44
- Gas/Air Leak36
- Display or Visual Feedback Problem29
- Device Contamination with Body Fluid23
- Inability to Auto-Fill22
- Failure to Sense18
- Leak/Splash17
- Noise, Audible16
Patient problems
- No Clinical Signs, Symptoms or Conditions299
- Insufficient Information69
- No Consequences Or Impact To Patient9
- Abdominal Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Air Embolism1
- Ischemia Stroke1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 326 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Failure to Read Input Signal
It was reported by clinical engineer that during use, the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. Patient involved. No harm reported. Optic sensor not detecting signal has been reported. Upon connecting the IAB optical sensor connector, an "IAB optical sensor module malfunction" alarm immediately occurred, preventing calibration and arterial pressure measurement using the optical sensor. Checking by unplugging and replugging the connector did not resolve the issue, so the patient was switched to another IABP (CARDIOSAVE), where the optical sensor functioned without problems. FSE reported customer about possible fault with optical sensor module, customer decided that repair is not necessary as it would be costly. No onsite work was required. Issue resolved over telephone. The customer canceled the repair.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865374 ↗MalfunctionSep 17, 2026Unexpected Shutdown
It was reported by the customer that during a scheduled inspection the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. System malfunction fault 45 occured. No patient involved and no harm is reported. It was reported that customer stated that repairs will not be performed as the equipment will be updated, and no verification is necessary.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799197 ↗MalfunctionAug 11, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205544 ↗MalfunctionMay 12, 2026Electrical /Electronic Property Problem; Failure to Read Input Signal; Date/Time-Related Software Problem; Calibration Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING THE PRE USE CHECK, THE CS300 INTRA AORTIC BALLOON PUMP (IABP) MALFUNCTIONED, THE HELIUM LEVEL INDICATOR WAS DISPLAYED TEMPORARILY BUT THEN DISAPPEARED. MAINTENANCE REQUEST CODE #5 WAS ALSO DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147617 ↗MalfunctionApr 21, 2026Gas/Air Leak; Air/Gas in Device
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE CS300, JAPANESE, NON-UTS, DOM INTRA-AORTIC BALLOON PUMP (IABP) HAD A MESSAGE INDICATING GAS INFLOW OCCURRED, BUT IT WAS RESOLVED, SO SYNCHRONIZATION CONTINUED. THERE WAS NO REPORTED HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934797 ↗MalfunctionApr 7, 2026Mechanical Problem; Suction Problem
IT WAS REPORTED THAT IN CS300 INTRA AORTIC BALLOON PUMP(IABP) THE VACUUM SUCTION WAS REDUCED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799653 ↗MalfunctionApr 3, 2026Failure to Transmit Record; Noise, Audible
IT WAS REPORTED BY CUSTOMER THAT DURING MONTHLY OPERATIONAL CHECKS THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD PRINTER MALFUNCTION AND UNUSUAL NOISE COMING FROM THE VOLUME CYLINDER (BINBA). THERE WAS NO PATIENT INVOLVEMENT. NO HARM IS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777469 ↗MalfunctionMar 20, 2026Calibration Problem
DURING IN-HOSPITAL INSPECTION CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DISPLAYING MAINTENANCE REQUEST CODE #5 (HELIUM TRANSDUCER CALIBRATION ERROR). THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647470 ↗MalfunctionMar 9, 2026Failure to Read Input Signal
IT WAS REPORTED THAT THE CS300, ECG WAVEFORM NOT INPUT EXTERNALLY. WHEN AN ELECTROCARDIOGRAM SIGNAL WAS INPUT INTO THE EXTERNAL INPUT UNIT IN PREPARATION FOR STARTING TREATMENT, THE WAVEFORM WAS NOT INPUT. HEALTHCARE PROFESSIONAL TRYING TO CHANGE CABLES AND DID NOT IMPROVE THE SITUATION, SO THEY SWITCHED TO ANOTHER MACHINE AND STARTED TREATMENT. THE SWITCH ITSELF ONLY TOOK A FEW MINUTES, AND AS IT WAS DURING PREPARATION FOR STARTING TREATMENT, THERE WAS NO DELAY IN TREATMENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. THERE WAS NO PATIENT INVOLVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547348 ↗MalfunctionMar 3, 2026Inability to Auto-Fill
IT WAS REPORTED THAT DURING USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTOMATIC FILLING ERROR OCCURRED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492831 ↗MalfunctionFeb 18, 2026Display or Visual Feedback Problem; Connection Problem
IT WAS REPORTED BY CUSTOMER DURING USE THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S SCREEN BECAME DISTORTED DURING CLINICAL USE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374339 ↗MalfunctionFeb 12, 2026Device Contamination with Body Fluid
IT WAS REPORTED THAT THE CS300 EXPERIENCED A BALLOON RUPTURE, WHICH MAY HAVE ALLOWED BLOOD TO BE DRAWN INTO THE DEVICE. HOWEVER, UPON INSPECTION, NO BLOOD WAS FOUND INSIDE THE DEVICE AND NO ISSUES WERE IDENTIFIED. NO HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320263 ↗MalfunctionFeb 10, 2026Moisture or Humidity Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) HAD A LARGE AMOUNT OF WATER DROPLETS IN THE BALLOON AND EXTENSION TUBE AND HAD AUTOMATIC FILLING ERROR. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302170 ↗MalfunctionJan 29, 2026Device Contamination with Body Fluid
MalfunctionJan 16, 2026Device Contamination with Body Fluid; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED A BALLOON RUPTURE WHILE USING A TRP4046 CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT BALLOON, AND THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091882 ↗MalfunctionDec 20, 2025No Device Output; Connection Problem; No Device Output; Connection Problem
MalfunctionDec 14, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED BY FSE THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) CONTINUED TO LEAK GAS. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799060 ↗MalfunctionNov 28, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid
IT WAS REPORTED THAT DURING USE ON PATIENT, BALLOON RUPTURED. AND BLOOD ENTERED THE CS300 INTRA-AORTIC BALLOON PUMP (IABP). NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669718 ↗MalfunctionNov 27, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
MalfunctionNov 24, 2025Unexpected Shutdown; Unexpected Shutdown
MalfunctionNov 4, 2025Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak
MalfunctionOct 31, 2025No Device Output; Optical Problem; No Device Output; Optical Problem
IT WAS REPORTED BY CUSTOMER THAT BEFORE USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD ARTERIAL PRESSURE OPTICAL SENSOR MODULE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433389 ↗MalfunctionOct 30, 2025No Device Output; No Device Output
IT WAS REPORTED THAT WHEN INSERTING THE FIBER OPTIC MODULE FOR USE IN TREATMENT, THE CS300 INTRA AORTIC BALLOON PUMP (IABP) HAD A LOOSE OPTICAL SENSOR CONNECTION WHEN THE OPTICAL SENSOR WAS INSERTED INTO THE FIBER OPTIC MODULE FOR TREATMENT. AS A RESULT, THE DEVICE WAS REPLACED WITH ANOTHER IABP AND TREATMENT WAS STARTED. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424612 ↗MalfunctionOct 27, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem
MalfunctionSep 19, 2025Inability to Auto-Fill; Gas/Air Leak; Inability to Auto-Fill; Gas/Air Leak
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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