CS300 Intra-Aortic Balloon Pump, French, 220V 0998-00-3023-64Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, French, 220V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS300 intra-aortic balloon pump has 81 adverse event reports, with no deaths and no injuries; all 81 describe malfunctions. Reports mention display problems, compressor issues, fiber-optic faults, shutdowns and inflation failures, often during checks or maintenance with no patient involved. It has no recalls. Reports fell from 10 to 4 in the most recent 12 months.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10607567108308), received between Nov 18, 2020 and Sep 4, 2026 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (10 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 Available11
- Erratic or Intermittent Display10
- Display or Visual Feedback Problem8
- Inability to Auto-Fill6
- No Display/Image6
- Battery Problem5
- Gas/Air Leak5
- Failure to Power Up4
Patient problems
- No Clinical Signs, Symptoms or Conditions74
- Insufficient Information27
- No Consequences Or Impact To Patient3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50606568 ↗MalfunctionJan 23, 2026Mechanical Problem
DURING PREVENTIVE MAINTENANCE END USER OBSERVED CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS HAVING DEFECTIVE COMPRESSOR. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24158549 ↗MalfunctionNov 12, 2025Inability to Auto-Fill; No Device Output; Inability to Auto-Fill; No Device Output
IT WAS REPORTED BY THE CUSTOMER DURING THE ROUTINE CHECK THAT THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) HAD A FIBER-OPTIC MALFUNCTION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532844 ↗MalfunctionNov 11, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD SHUT DOWN WHEN THE DEVICE WAS TURNED ON. THE DEVICE SHUTS DOWN AS SOON AS IT IS TURNED ON. IT WAS CONNECTED TO A PATIENT AND STARTED TO BEEP. THE DEVICE WAS REMOVED FROM THE PATIENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23520491 ↗MalfunctionNov 4, 2025Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available
MalfunctionOct 17, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE ON/OFF SWITCH OF CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DEFECTIVE. THERE WAS NO HARM REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23320422 ↗MalfunctionOct 15, 2025Unexpected Shutdown; Unexpected Shutdown
MalfunctionJun 30, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) NO LONGER INFLATES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22356137 ↗MalfunctionJun 12, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD FROZEN SCREEN AND THE DISPLAY IS FULL OF COLOURS MAKING IT IMPOSSIBLE TO WORK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192801 ↗MalfunctionApr 2, 2025Power Problem; Power Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A POWER SUPPLY PROBLEM. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749552 ↗MalfunctionFeb 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED BY THE CUSTOMER THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A FALSE SCREEN CONTACT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397240 ↗MalfunctionFeb 18, 2025Output Problem; Output Problem
IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD ECG CABLE FAILURE. THE FAILURE OCCURRED DURING USE ON PATIENT.
Patient problems: Insufficient Information
MAUDE report 21396178 ↗MalfunctionJan 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED DURING START UP THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD ERROR #7. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21134577 ↗MalfunctionJan 10, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT CS300 INTRA AORTIC BALLOON PUMP HAD A SPEAKER PROBLEM. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY AS THE REPORTED EVENT OCCURED DURING PREVENTIVE MAINTENANCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21122115 ↗MalfunctionNov 26, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HELIUM LEAK PROBLEM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20789696 ↗MalfunctionOct 23, 2024Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) AUTO PURGE FAILED.
Patient problems: Insufficient Information
MAUDE report 20517044 ↗MalfunctionOct 8, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) ECG SIGNAL DOES NOT GO BACK TO THE CONSOLE DESPITE THE CHANGE OF CABLE.
Patient problems: Insufficient Information
MAUDE report 20395944 ↗MalfunctionAug 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS ERROR 50 MOTOR SPEED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003101 ↗MalfunctionAug 1, 2024Pumping Stopped; Pumping Stopped
MalfunctionJun 28, 2024No Device Output; No Device Output
IT WAS REPORTED THAT DURING PATIENT USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A WAVE FORM ISSUE. THE UNIT WAS PRINTING ONLY VERY SHORT (1 SECOND) CLIPS OF THE WAVEFORMS AND NOT DOSSING TO THEIR PATIENT INFORMATION SERVER. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19637679 ↗MalfunctionMay 17, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BLACK SCREEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19339308 ↗MalfunctionApr 4, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
MalfunctionMar 19, 2024Component Missing; Component Missing
MalfunctionFeb 6, 2024Failure to Charge; Failure to Power Up; Failure to Charge; Failure to Power Up
MalfunctionOct 19, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN DOES NOT RESPOND TO SWITCHING ON, BLACK, NO VOLTAGE INDICATOR LIGHT WHILE THEY CAN CLEARLY HEAR THE FAN RUNNING DOWNSTAIRS.
Patient problems: Insufficient Information
MAUDE report 17965654 ↗
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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