CS300 Intra-Aortic Balloon Pump, Spanish, 220V 0998-00-3023-58Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, Spanish, 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 bedside machine that inflates a balloon in the aorta to help the heart pump blood during cardiac care. The 64 reports mostly describe equipment problems found during servicing — screens or control buttons not working, batteries needing replacement, gas or air leaks, and units shutting off on their own — with no patient involved and no deaths or injuries reported. 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
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10607567108339), received between Jan 21, 2021 and Sep 28, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (7 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 Available17
- Display or Visual Feedback Problem7
- Gas/Air Leak6
- Battery Problem5
- Break5
- Inability to Auto-Fill5
- Failure to Power Up3
- Unexpected Shutdown3
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- Insufficient Information20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Read Input Signal
It was reported by the customer that during a routine check the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. Optical display not working has been reported. The customer stated the optical sensor was not functional. No patient was involved. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE tested the fiber optic function and it worked as expected, the issue with the pump could not be reproduced. The values are correct and pass the test. Equipment is suitable for clinical use. No parts to be replaced or returned. The unit passed all functional and safety tests to manufacturer specifications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912777 ↗MalfunctionSep 24, 2026Battery Problem
It was reported by the customer that during routine check, the CS300 Intra-Aortic Balloon Pump (IABP) the batteries need to be replaced because they do not last the minimum required time. There was no patient involvement and no harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that batteries replaced and proper operation verified for clinical use. Product passed all functional and safety tests per manufacturer specifications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877703 ↗MalfunctionJan 5, 2026Display or Visual Feedback Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING PM THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) SCREEN NOT WORKING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954944 ↗MalfunctionDec 11, 2025No Display/Image; No Display/Image
IT WAS REPORTED BY THE CUSTOMER THAT CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREEN FAILURE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780598 ↗MalfunctionDec 11, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
MalfunctionJul 31, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED BY THE FIELD SERVICE ENGINEER (FSE) THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) BUTTONS DIDN'T WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22673961 ↗MalfunctionJul 31, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT BATTRIES OF CS300 INTRA AORTIC BALLOON PUMP (IABP) NEED TO CHANGE. THERE WAS NO HARM OR INJURY REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22672991 ↗MalfunctionJul 21, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact
IT WAS REPORTED BY CUSTOMER THAT THE DISPLAY OF CS300 INTRA AORTIC BALLOON PUMP ( IABP) WAS SHOWING HORIZONTAL LINES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553174 ↗MalfunctionJun 4, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SHUTS OFF BY ITSELF.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22140872 ↗MalfunctionApr 4, 2025Electrical /Electronic Property Problem; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available
MalfunctionMar 24, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD GAS LOSS ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675550 ↗MalfunctionMar 17, 2025Display or Visual Feedback Problem; Appropriate Device Problem Term/Code Not Available; Display or Visual Feedback Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE ON THE PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD ALARM ON THE DISPLAY. THERE WAS NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616670 ↗MalfunctionMar 12, 2025Gas Output Problem; Gas Output Problem
IT WAS REPORTED BY CUSTOMER DURING USE THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) COUNTERPULSATION BALLOON CONSOLE GIVES A LOW VACUUM ERROR. NO PATIENT HARM OR INJURY REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21581610 ↗MalfunctionJan 21, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT, DURING PREVENTIVE MAINTENANCE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD KEYPAD USER INTERFACE MALFUNCTION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21195915 ↗MalfunctionJan 10, 2025Break; Break
MalfunctionJan 7, 2025Pressure Problem; Pressure Problem
MalfunctionNov 19, 2024Battery Problem; Battery Problem
IT WAS REPORTED DURING A ROUTINE CHECK ,THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERIES ARE FAILING .THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20727235 ↗MalfunctionNov 1, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WHEEL BROKE, THE RUBBER FAILED. THERE WAS NO PATIENT INVOLVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20588048 ↗MalfunctionOct 22, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS HELIUM LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20505822 ↗MalfunctionSep 6, 2024Battery Problem; Battery Problem
IT WAS REPORTED DURING THE STARTUP ROUTINE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY NEEDED TO BE CHANGED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20162514 ↗MalfunctionSep 4, 2024Decrease in Suction; Decrease in Suction
IT WAS REPORTED THAT BEFORE THERAPY DURING THE START-UP ROUTINE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS LOW VACUUM ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137675 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) ENTRANCE FOR CONNECTING THE COUNTERPULSATION BALLOON CATHETER IS BROKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19928384 ↗MalfunctionJul 5, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING A ROUTINE CHECK, PRIOR TO USE, THE SCREEN ON THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679768 ↗MalfunctionMay 14, 2024False Alarm; False Alarm
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT GIVES FALSE BALLOON CHECK ALARM TO CHECK THE BALL.
Patient problems: Insufficient Information
MAUDE report 19310696 ↗MalfunctionApr 22, 2024Break; Break
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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