CS100 Intra-Aortic Balloon Pump, Italian, 220V 0998-00-3013-67Recalls & reported problems
Datascope Corp. · CS100 Intra-Aortic Balloon Pump, Italian, 220V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS100 intra-aortic balloon pump is a bedside machine that helps a patient's heart pump blood during surgery. The 64 reports since 2020 mostly describe display and screen glitches, air or gas leaks, blood getting into the equipment, the pump failing to fill on its own, broken parts, and unreliable ECG signal readings. No deaths or injuries were reported, and 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
- 65
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10607567107486), received between Dec 22, 2020 and Sep 7, 2026 — classified as 65 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (7 reports).
8 other recalls cover devices cleared under the same FDA submission (K031636); they may or may not involve this specific model.
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 Available12
- Display or Visual Feedback Problem7
- Break5
- Gas/Air Leak5
- Inability to Auto-Fill5
- Failure to Read Input Signal4
- Insufficient Device Problem Information4
- No Display/Image4
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Insufficient Information11
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2026No Display/Image; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649433 ↗MalfunctionApr 2, 2026Display or Visual Feedback Problem; Poor Quality Image
IT WAS REPORTED THAT THE CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD DISPLAY IMAGE ANOMALY, UNSTABLE VISION BEFORE USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24762398 ↗MalfunctionFeb 26, 2026Fluid/Blood Leak
MalfunctionFeb 15, 2026Device Contamination with Body Fluid
IT WAS REPORTED BY CUSTOMER DURING USE THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD BLOOD BACK IN THE EQUIPMENT ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341400 ↗MalfunctionFeb 6, 2026Failure to Read Input Signal
IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECK THAT THE CS100 INTRA AORTIC BALLOON PUMP (IABP) UNIT HAD INTERMITTENT READING OF THE ECG SIGNAL ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276475 ↗MalfunctionDec 19, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid
IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V INTRA-AORTIC BALLOON PUMP (IABP) WAS FAULTY DUE TO BLOOD INVASION. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848396 ↗MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT BEFORE USE, CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD HELIUM LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777843 ↗MalfunctionNov 25, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Loose or Intermittent Connection; Erratic or Intermittent Display; Display or Visual Feedback Problem; Loose or Intermittent Connection
MalfunctionNov 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT IN CS100 INTRA AORTIC BALLOON PUMP, THERE WAS AN UNSPECIFIED MALFUNCTION, THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495590 ↗MalfunctionOct 28, 2025Filling Problem; Filling Problem
IT WAS REPORTED BY THE CUSTOMER THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD FAILED HELIUM FILLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401742 ↗MalfunctionOct 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED A MESSAGE TO CHECK CATHETER. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400290 ↗MalfunctionOct 27, 2025Failure to Read Input Signal; Failure to Read Input Signal
IT WAS REPORTED THAT ,BEFORE USE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS FAULT IN THE ECG CABLE SOCKET SYSTEM THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390066 ↗MalfunctionOct 15, 2025Contamination; Electrical /Electronic Property Problem; Device Contamination with Body Fluid; Appropriate Device Problem Term/Code Not Available; Contamination; Electrical /Electronic Property Problem; Device Contamination with Body Fluid; Appropriate Device Problem Term/Code Not Available
MalfunctionJul 30, 2025Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT CS300 INTRA AORTIC BALLOON PUMP (IABP) WAS GIVING ERROR ALARM 52 AT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662565 ↗MalfunctionJul 29, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DOES NOT PASS SAFETY DISC SEAL TEST. THERE WAS NO PATIENT INVOLVED AND NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22640686 ↗MalfunctionJul 9, 2025Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS VIBRATING AND WAS UNREADABLE. HOWEVER, THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456327 ↗MalfunctionMay 13, 2025Failure to Read Input Signal; Failure to Read Input Signal
IT WAS REPORTED BY CUSTOMER THAT BEFORE USE, THE CS100 INTRA AORTIC BALLOON PUMP DOES NOT RECOGNIZE ECG CABLE SIGNAL AND MONITOR, IT DARKENED WITHOUT BEING ABLE TO SEE THE PARAMETERS. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22015778 ↗MalfunctionFeb 18, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem
IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD OXIDIZED HELIUM CYLINDER ISSUE . THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21393462 ↗MalfunctionJan 7, 2025Inability to Auto-Fill; Battery Problem; Inability to Auto-Fill; Battery Problem
N/A
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21089791 ↗MalfunctionJan 2, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING POWER-UP THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAS SYSTEM FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21052755 ↗MalfunctionOct 29, 2024Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A KEYBOARD ANOMALY ON THE CONTROL PANEL, EXPIRED BATTERIES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555250 ↗MalfunctionOct 23, 2024Break; No Display/Image; Break; No Display/Image
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD BROKEN WHEELS AND AN OUT OF SYNC DISPLAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517613 ↗MalfunctionOct 22, 2024Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A PROBLEM WITH THE MONITOR, SHOWED UNCLEAR AND FLICKERING IMAGES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20510069 ↗MalfunctionOct 22, 2024Inability to Auto-Fill; Failure to Read Input Signal; Inability to Auto-Fill; Failure to Read Input Signal
MalfunctionOct 11, 2024Unexpected Shutdown; Unexpected Shutdown
Recalls under the same FDA submission
These recalls involve devices cleared under K031636. One submission often covers many models, so check the product and lot details in each record.
- Z-1486-2026 · Jan 23, 2026 · Open, ClassifiedCS100 IABP. Software Version CS100 IABP Q.01.
- Z-3085-2017 · Jul 17, 2017 · Open, ClassifiedCS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by a
- Z-3086-2017 · Jul 17, 2017 · Open, ClassifiedCS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by au
- Z-2736-2017 · Jun 16, 2017 · TerminatedCS 100i Intra-Aortic Balloon Pump
- Z-2737-2017 · Jun 16, 2017 · TerminatedCS 100 Intra-Aortic Balloon Pump
- Z-1523-2014 · Mar 21, 2014 · TerminatedDatascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate in
- Z-2414-2011 · Mar 16, 2011 · TerminatedDatascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 130
- Z-1811-2010 · May 10, 2010 · TerminatedCS100 Intra-Aortic Balloon Pump.
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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