CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOM 0998-UC-3013-53Recalls & reported problems
Datascope Corp. · CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,DOM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS100 intra-aortic balloon pump is a refurbished pump that drives a balloon placed in the aorta. All 160 reports are malfunctions, and many describe the pump failing to auto-fill, failing to power up, or showing unclear displays. The reports include no deaths or injuries. 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
- 160
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 10607567107745), received between Sep 17, 2020 and Apr 25, 2025 — classified as 160 malfunctions.
The most frequently reported specific device problem is “Inability to Auto-Fill” (22 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 Available22
- Inability to Auto-Fill22
- Failure to Power Up21
- Display or Visual Feedback Problem13
- Battery Problem11
- Erratic or Intermittent Display9
- Device Displays Incorrect Message8
- No Display/Image8
Patient problems
- No Clinical Signs, Symptoms or Conditions120
- No Patient Involvement40
- Insufficient Information21
- No Known Impact Or Consequence To Patient16
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) RECEIVED A "DISCONNECTED" ERROR ON A CS300 BUT STATES THAT "ALL WIRES AND TUBES WERE CONNECTED." FURTHER REPORTED THAT PATIENT WAS NOT MOVING AND HELIUM TANK LEVEL WAS ACCEPTABLE AND CS300 GOES INTO STANDBY AUTOMATICALLY DURING "IAB DISCONNECTED" ALARM. THERE WAS NO HARM REPORTED TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907536 ↗MalfunctionMay 17, 2024Decrease in Suction; Decrease in Suction
MalfunctionMar 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MalfunctionMar 6, 2024Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTO FILL FAILURE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18846159 ↗MalfunctionFeb 21, 2024Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SMELLED WHEN TANK WAS OPENED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18754337 ↗MalfunctionFeb 9, 2024Battery Problem; Battery Problem
MalfunctionSep 19, 2023Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOFILL FAILURE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17777078 ↗MalfunctionSep 14, 2023Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AUTOFILL ERRORS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17745110 ↗MalfunctionJul 14, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A LOW BATTERY BACKUP ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324571 ↗MalfunctionApr 25, 2023Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED DURING A ROUTINE CHECK THE CS100 INTRA-AORTIC BALLOON PUMP (IABP)HAD AN AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED .
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16809974 ↗MalfunctionApr 25, 2023Failure to Sense; Failure to Sense
IT WAS REPORTED THAT DURING ROUTINE CHECKUP, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DOPPLER WAS NOT SENSING THE PULSES.
Patient problems: Insufficient Information
MAUDE report 16806173 ↗MalfunctionApr 24, 2023Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) ELECTRICAL ERROR CODE 117. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16795980 ↗MalfunctionApr 5, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT DURING ROUTINE CHECK BY CUSTOMER, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS NOT TURNING ON.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16684978 ↗MalfunctionApr 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING PRE USE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A LOW VACUUM ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674949 ↗MalfunctionMar 28, 2023Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) OBSERVED THAT SYSTEM IS SHOWING ELECTRICAL TEST FAILURE #52.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16627779 ↗MalfunctionMar 28, 2023No Display/Image; No Display/Image
MalfunctionMar 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS CASTER IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16565866 ↗MalfunctionMar 16, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) IS SHOWING A JITTERY DISPLAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553769 ↗MalfunctionFeb 28, 2023Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) CUSTOMER COMPLAINED ABOUT MAINTENANCE REQUIRED CODE 1. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16454493 ↗MalfunctionFeb 24, 2023Power Problem; Power Problem
IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) IS NOT SWITCHING ON AND ALSO THE POWER SUPPLY IS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16436729 ↗MalfunctionFeb 17, 2023Power Problem; Power Problem
IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS GIVING CONTINUOUS BEEPING SOUND WHEN SWITCHING MACHINE ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16396105 ↗MalfunctionFeb 10, 2023Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTO FILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350417 ↗MalfunctionFeb 6, 2023Battery Problem; Battery Problem
MalfunctionJan 30, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PATIENT USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD CONDENSATION. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16264437 ↗MalfunctionJan 27, 2023Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT PRIOR TO USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) CRASHED. THE UNIT ALARMED FOR THE REPORTED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16257778 ↗
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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