CS300 Intra-Aortic Balloon Pump, German, 220V 0998-00-3023-61Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, German, 220V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS300 intra-aortic balloon pump is a machine that inflates and deflates a balloon in the aorta to help the heart pump during surgery or critical care. The 45 reports mostly describe display and screen problems, the monitor not working or showing only lines, and low vacuum or error codes found during testing or maintenance. Two deaths and no injuries are reported. There are no recalls naming this device, and reports have dropped from 10 in the earlier12 months to 3 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
- 45
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10607567108278), received between Sep 30, 2020 and Mar 30, 2026 — classified as 2 deaths, 43 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (6 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 Available7
- Display or Visual Feedback Problem6
- Failure to Sense4
- Electrical /Electronic Property Problem3
- Erratic or Intermittent Display3
- No Display/Image3
- Battery Problem2
- Decrease in Pressure2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Insufficient Information8
- No Known Impact Or Consequence To Patient3
- Aneurysm2
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Decrease in Pressure
IT WAS REPORTED THAT DURING MAINTENANCE TESTING CS300 INTRA-AORTIC BALLOON PUMP (IABP), IT WAS FOUND THAT THE VACUUM WAS BELOW MINIMUM VALUES. AFTER SEVERAL TESTS, IT WAS CONCLUDED THAT THE PROBLEM WAS WITH THE COMPRESSOR ITSELF. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24710847 ↗MalfunctionFeb 25, 2026Electrical /Electronic Property Problem; Noise, Audible
IT WAS REPORTED THAT BEFORE USE, THE CS300 INTRA AORTIC BALLOON PUMP (IABP) DISPLAYED AN ELECTRICAL TEST FAILURE CODE # 50 (MOTOR SPEED OUT OF SPECIFICATION). NO PATIENT WAS INVOLVED, AND NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444409 ↗MalfunctionDec 8, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) MONITOR WAS NOT WORKING AND ONLY LINES WERE VISIBLE ON THE SCREEN. THE ISSUE OCCURRED DURING INITIAL TEST BEFORE USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23736604 ↗MalfunctionSep 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
MalfunctionJul 3, 2025Electrical /Electronic Property Problem; Decrease in Pressure; Infusion or Flow Problem; Electrical /Electronic Property Problem; Decrease in Pressure; Infusion or Flow Problem
IT WAS REPORTED BY CUSTOMER THAT DURING USE THE CS300 INTRA AORTIC BALLOON PUMP HAD DISPLAYED LOW VACUUM ALARM FOLLOWED BY ELECTRICAL CODE ERROR 50. THERE WAS NO INJURY OR THREAT TO THE PATIENT OR OTHER PERSON. USE ANOTHER DEVICE CS100 PUMP TO CONTINUE THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393942 ↗MalfunctionJun 20, 2025Fluid/Blood Leak; Device Contamination with Body Fluid; Gas/Air Leak; Fluid/Blood Leak; Device Contamination with Body Fluid; Gas/Air Leak
IT WAS REPORTED BY GETINGE FIELD SAFETY ENGINEER DURING MAINTENANCE THE CS300 INTRA AORTIC BALLOON PUMP (IABP) CUSTOMER DISCOVERED THAT THERE WAS BLOOD IN THE SYSTEM AND LEAK IN THE IABP CATHETER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22295045 ↗MalfunctionJun 11, 2025Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) FAILED DURING AUTOFILL AND EXPERIENCED AN AUTOFILL FAILURE ALARM DURING USE ON PATIENT. THERE WAS NO INJURY OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182280 ↗MalfunctionApr 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown; Incorrect, Inadequate or Imprecise Result or Readings; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown
IT WAS REPORTED BEFORE USE THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD UNSPECIFIED MALFUNCTION. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882490 ↗MalfunctionMar 17, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING USE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTOLOAD SYSTEM FAILURE (FAULT 57) . THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21617630 ↗MalfunctionMar 17, 2025Optical Problem; Optical Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING DAILY INSPECTION, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN OPTICAL SENSOR FAILURE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616090 ↗MalfunctionFeb 24, 2025Power Problem; Power Problem
IT WAS REPORTED THAT DURING USE ON PATIENT, CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED THE MESSAGE "MAINTENANCE REQUIRED CODE #7". THERE WAS NO INJURY OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444269 ↗MalfunctionFeb 3, 2025Calibration Problem; Calibration Problem
N/A
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21292379 ↗MalfunctionDec 2, 2024Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image
MalfunctionOct 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHEN TURNING ON THE EQUIPMENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS ELECTRICAL FAULT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20505911 ↗MalfunctionSep 13, 2024Decrease in Suction; Decrease in Suction
MalfunctionJul 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING DAILY USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY IS DEFECTIVE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19878182 ↗MalfunctionMay 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
N/A
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19355112 ↗MalfunctionMay 20, 2024Failure to Sense; Failure to Sense
MalfunctionApr 30, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) ALARM WENT OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19216431 ↗MalfunctionApr 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FIBER OPTIC COVER WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209942 ↗MalfunctionFeb 19, 2024Break; Break
IT WAS REPORTED THAT WHILE MOVING THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DEVICE FROM CARDIOLOGY STORAGE UNIT TO THE OPERATING ROOM, THE HOLDING ARM BROKE OFF AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730630 ↗MalfunctionNov 17, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING A ROUTINE CHECL AFTER SWITCHING ON THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FLAT SCREEN MONITOR CONSTANTLY FLICKERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18163076 ↗MalfunctionAug 15, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S DISPLAY WAS DAMAGED. THE DISPLAY FLICKERED AS SOON AS IT WAS SWITCHED ON. A DIFFERENT DEVICE/THERAPY WAS THEN USED FOR THE TREATMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17547916 ↗MalfunctionMay 4, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) THE DEVICE FAILED THE BATTERY TEST, THE BATTERIES DID NOT REACH THE REQUIRED MINIMUM RUNTIME AND THE DEVICE SWITCHED OFF AFTER AROUND 98 MINUTES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16868754 ↗MalfunctionMar 24, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A BROKEN LCD SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16610979 ↗
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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