CS300 Intra-Aortic Balloon Pump, Italian, 220V 0998-00-3023-67Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, Italian, 220V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS300 intra-aortic balloon pump has 200 adverse event reports, with no deaths and no injuries. Many reports describe display problems such as flickering or blank screens, gas leaks, failing to auto-fill, and battery faults, often found before use, with no patient involvement reported. There are no recalls that 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
- 201
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 10607567112619), received between Jun 9, 2021 and Sep 28, 2026 — classified as 201 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (30 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 Available30
- Display or Visual Feedback Problem30
- No Display/Image16
- Gas/Air Leak15
- Break11
- Battery Problem10
- Electrical /Electronic Property Problem10
- Erratic or Intermittent Display10
Patient problems
- No Clinical Signs, Symptoms or Conditions193
- Insufficient Information34
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 201 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Image Display Error/Artifact
It was reported by the customer that before use the CS300 Intra-Aortic Balloon Pump (IABP) monitor had a malfunction. There was no patient involvement, no harm reported. Field Service Engineer (FSE) arrived on site and reported that the display shows artifacts and is not readable. FSE performed display disassembly and internal contact cleaning. Display connector contact cleaning. Replacing the flat cable video receiver to LCD. Functional tests performed successfully. The equipment has been returned to the customer for clinical use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911690 ↗MalfunctionSep 22, 2026Device Alarm System
It was reported by the customer that during tests before use, the CS300 Intra-Aortic Balloon Pump (IABP) various alarms had occurred. There was no patient involvement. No harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852347 ↗MalfunctionSep 15, 2026Computer Software Problem
It was reported that during routine check the CS300 Intra-Aortic Balloon Pump (IABP) error 50 occurred. No patient involvement. No harm reported. The issue discovered by the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50768945 ↗MalfunctionSep 10, 2026Electrical /Electronic Property Problem
MalfunctionJul 31, 2026Unexpected Shutdown
MalfunctionApr 21, 2026Display or Visual Feedback Problem
MalfunctionApr 15, 2026Charging Problem
MalfunctionApr 14, 2026Battery Problem
IT WAS REPORTED THAT CS300 HAD BATTERY FAILURE ALARM. THE DEVICE INDICATES THAT THE BATTERY REQUIRES MAINTENANCE. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24869354 ↗MalfunctionApr 10, 2026No Display/Image
MalfunctionApr 2, 2026Failure to Zero
IT WAS REPORTED BY CUSTOMER THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) FACING ISSUE WITH UNABLE TO ZERO THE PRESSURE DURING PREPARATION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764828 ↗MalfunctionApr 1, 2026Charging Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) MALFUNCTIONED. THE CLIENT REPORTED THAT BATTERIES DO NOT HOLD A CHARGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752113 ↗MalfunctionMar 23, 2026Erratic or Intermittent Display; Image Display Error/Artifact
IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE CHECK UP, CS300 MONITOR WAS NOT WORKING ,IMAGE FLICKERING.THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659483 ↗MalfunctionMar 18, 2026Battery Problem
MalfunctionMar 10, 2026Display or Visual Feedback Problem
IT WAS REPORTED BY CUSTOMER BEFORE USE, THAT CS300 HAD FAULTY DISPLAY. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562086 ↗MalfunctionMar 4, 2026Battery Problem
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) DOES NOT HOLD CHARGE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504585 ↗MalfunctionFeb 24, 2026Leak/Splash; Gas/Air Leak
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP(IABP) HAD HELIUM LEAK. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430531 ↗MalfunctionFeb 20, 2026Display or Visual Feedback Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE CS300 INTRA-AORTIC BALLOON PUMP DISPLAY WAS NOT WORKING WHILE THE DEVICE WAS IN STANDBY MODE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399461 ↗MalfunctionFeb 17, 2026Charging Problem; Gas/Air Leak; Overcorrection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE CUSTOMER THAT DURING CHECK THE COUNTER-AORTIC CS300 INTRA-AORTIC BALLOON PUMP(IABP) DOES NOT HOLD THE BATTERY CHARGE AND REPORTS MAINTENANCE CODE #3. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368716 ↗MalfunctionFeb 2, 2026Failure to Read Input Signal
MalfunctionJan 13, 2026Battery Problem
IT WAS REPORTED BY CUSTOMER THAT CS300 CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BATTERY MAINTENANCE REQUIRED MESSAGE. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050997 ↗MalfunctionJan 12, 2026Charging Problem
IT WAS REPORTED BY THE CUSTOMER DURING ROUTINE CHECK THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DEVICE DOES NOT CHARGE, PROBABLY POWER SUPPLY DAMAGE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034742 ↗MalfunctionJan 8, 2026Battery Problem
IT WAS REPORTED DURING CHECK THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) REQUIRED BATTERY MAINTENANCE. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001671 ↗MalfunctionDec 22, 2025Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT BEFORE USE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO FILL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862188 ↗MalfunctionDec 12, 2025Filling Problem; Suction Problem; Gas/Air Leak; Filling Problem; Suction Problem; Gas/Air Leak
N/A.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23788296 ↗MalfunctionDec 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
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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