CS100 Intra-Aortic Balloon Pump, Portuguese, 220V 0998-00-3013-68Recalls & reported problems
Datascope Corp. · CS100 Intra-Aortic Balloon Pump, Portuguese, 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 machine that helps the heart pump blood during cardiac procedures. The 49 reports mostly describe malfunctions found during routine testing and maintenance — charging failures, batteries running down or failing early, unexpected shutdowns, distorted screen images and even damaged wheels — with no deaths and no injuries, and nearly all involving no patient at all. 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
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10607567107691), received between Sep 9, 2020 and Feb 6, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 Available10
- Break10
- Premature Discharge of Battery4
- Battery Problem3
- Electrical /Electronic Property Problem3
- Failure to Charge3
- Unexpected Shutdown3
- Failure to Power Up2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information15
- No Patient Involvement6
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Inability to Auto-Fill; Failure to Charge
IT WAS REPORTED THAT THE CS100 INTRA AORTIC BALLOON PUMP (IABP) DISPLAYED AN AUTOMATIC BALLOON CHARGING FAILURE MESSAGE DURING SYSTEM TESTING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276497 ↗MalfunctionDec 19, 2025Erratic or Intermittent Display; Image Display Error/Artifact; Erratic or Intermittent Display; Image Display Error/Artifact
IT WAS REPORTED THAT THE CARDIOSAVE CS100 HAD DISTORTED SCREEN IMAGE ISSUE WHILE DEVICE WAS IN DURING INITIAL TESTING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847716 ↗MalfunctionDec 3, 2025Break; Failure to Read Input Signal; Break; Failure to Read Input Signal
MalfunctionNov 8, 2025Inability to Auto-Fill; Break; Appropriate Device Problem Term/Code Not Available; Inability to Auto-Fill; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY USER THAT DURING INITIAL TESTS THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SYSTEM FAILURE AND BALLOON FAILED TO LOAD AUTOMATICALLY. NO PATIENT INVOLVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23505398 ↗MalfunctionMar 18, 2025Break; Break
MalfunctionJan 10, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY TEST FAILED AFTER 105MIN AND WAS STILL WITHIN THE EXPIRATION DATE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21121901 ↗MalfunctionOct 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT WHEN THE EQUIPMENT IS TURNED ON, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) IS ALARMING THE MEDICAL IT IN THE SURGICAL CENTER, CAUSING THE IMPEDANCE TO DROP. NO PATIENT WAS INVOLVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20397758 ↗MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD DAMAGED WHEELS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921376 ↗MalfunctionMay 8, 2024Break; Break
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , IT WAS NECESSARY TO REPLACE TWO CS100 INTRA-AORTIC BALLOON PUMP (IABP) CASTERS AS THEY HAD DAMAGED RUBBER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271021 ↗MalfunctionMar 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING PRE-USE TESTING, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT CYCLING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836021 ↗MalfunctionDec 11, 2023Backflow; Backflow
IT WAS REPORTED THAT THE DURING AN INSPECTION ON THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) BLOOD WAS IDENTIFIED ON THE SAFETY DISK. THERE WAS NO HARM OR INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18301688 ↗MalfunctionOct 3, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BLACK SCREEN. WHEN STARTING THE EQUIPMENT, THE SCREEN DOES NOT WORK. THERE WAS NO PATIENT INVOLVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17860468 ↗MalfunctionSep 15, 2023Degraded; Degraded
MalfunctionSep 11, 2023Failure to Power Up; Failure to Power Up
MalfunctionAug 17, 2023Break; Break
IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS DAMAGED WHEELS. THERE IS NO PATIENT INVOLVEMENT REPORTED .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17563109 ↗MalfunctionJun 6, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT , THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNITS WHEELS REPLACED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17074782 ↗MalfunctionMay 30, 2023Noise, Audible; Noise, Audible
IT WAS REPORTED THAT DURING USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS MAKING AN INTENSE NOISE, THE UNIT WAS REPLACED BY ANOTHER. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17018733 ↗MalfunctionMay 26, 2023Failure to Charge; Failure to Charge
IT WAS REPORTED THAT BEFORE USE DURING INITIAL TESTS, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT DOES NOT CHARGE BATTERIES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17009923 ↗MalfunctionMar 13, 2023Appropriate 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 16530661 ↗MalfunctionFeb 6, 2023Failure to Charge; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available; Failure to Charge; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS SHOWN OPERATING ERRORS.
Patient problems: Insufficient Information
MAUDE report 16302807 ↗MalfunctionFeb 2, 2023Break; Break
IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS BROKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16283377 ↗MalfunctionJan 31, 2023Break; Break
IT WAS REPORTED THAT THE DOPPLER IN THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS BROKEN. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THIS EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16271177 ↗MalfunctionJan 30, 2023Break; Break
IT WAS REPORTED THAT DURING A PREVENTATIVE MAINTENANCE (PM) SERVICE REPAIR PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), IT WAS OBSERVED THAT THE DOPPLER ON THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD THE LATCH ON THE ACCESS DOOR BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16263494 ↗MalfunctionJan 16, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS DAMAGED DURING TRANSPORT BETWEEN MAINLAND PORTUGAL AND THE HOSPITAL IN PONTA DELGADA IN THE AZORES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16178837 ↗MalfunctionJan 16, 2023Failure to Sense; Failure to Sense
IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT DOPPLER BOX IS BROKEN AND THE BATTERY COVER IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16178747 ↗
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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