CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTL 0998-UC-3013-55Recalls & reported problems
Datascope Corp. · CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTL · 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 heart support machine that inflates a balloon in the aorta. Of its 128 reports, 126 are malfunctions, 1 is an injury and 1 describes a death; some describe the pump failing to power up, failing to auto-fill, or showing erratic displays. Reports fell to 13 in the last 12 months from 31 in the 12 months before. 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
- 129
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10607567107875), received between Oct 15, 2020 and Aug 31, 2026 — classified as 1 death, 1 injury, 127 malfunctions.
The most frequently reported specific device problem is “Inability to Auto-Fill” (16 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
- Inability to Auto-Fill16
- Appropriate Device Problem Term/Code Not Available14
- Failure to Power Up13
- Electrical /Electronic Property Problem10
- Display or Visual Feedback Problem9
- Battery Problem8
- Erratic or Intermittent Display8
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions124
- Insufficient Information8
- No Patient Involvement3
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Headache1
- Nausea1
- Pain1
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515668 ↗MalfunctionJul 27, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017358 ↗MalfunctionMar 25, 2026Battery Problem
IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP)¿S DAMAGED BATTERIES WERE REPLACED DURING A TECHNICAL INSPECTION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685673 ↗MalfunctionMar 12, 2026Failure to Power Up
IT WAS REPORTED DURING A ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT SWITCHING ON MAINS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579545 ↗MalfunctionMar 6, 2026Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown
IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECK THAT CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD SYSTEM FAILURE ALARM AND PRESSURE PORT WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531770 ↗MalfunctionMar 2, 2026Electrical /Electronic Property Problem; Calibration Problem
IT WAS REPORTED BY CUSTOMER DURING ROUTINE CHECK THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD MAINTENANCE REQUIRED CODE #5. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24479037 ↗MalfunctionFeb 26, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING ROUTINE CHECK THE AUGMENTATION OF CS100 INTRA-AORTIC BALLOON PUMP(IABP) MALFUNCTIONED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453110 ↗MalfunctionFeb 24, 2026Calibration Problem; Appropriate Device Problem Term/Code Not Available
MalfunctionFeb 20, 2026Inability to Auto-Fill
IT WAS REPORTED THAT DURING A ROUTINE CHECK THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTO FAILURE ALARM. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24398829 ↗MalfunctionDec 29, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT BEFORE USE BY CUSTOMER, CS100 INTRA-AORTIC BALLOON PUMP (IABP) NOT SWITCHING ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905573 ↗MalfunctionDec 14, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT BEFORE USE, CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD ELECTRICAL TEST FAILURE #39. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799488 ↗MalfunctionDec 11, 2025Decrease in Pressure; Suction Problem; Output below Specifications; Decrease in Pressure; Suction Problem; Output below Specifications
IT WAS REPORTED BY THE CUSTOMER THAT THE CS100 INTRA-AORTIC BALLOON PUMP(IABP) WHEN TURNING ON THE DEVICE, IT FIRST STARTED REPORTING LOW VACUUM AND THEN ELECTRICAL ERROR CODE #50. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777297 ↗MalfunctionDec 4, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
MalfunctionNov 21, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT DURING ROUTINE CHECK, CS100 INTRA-AORTIC BALLOON PUMP (IABP) NOT SWITCHING ON MAINS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23614687 ↗MalfunctionOct 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Appropriate Device Problem Term/Code Not Available; Incorrect, Inadequate or Imprecise Result or Readings; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED SYSTEM TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310945 ↗MalfunctionSep 16, 2025Calibration Problem; Calibration Problem
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A CS100 MAINTENANCE REQUIRED CODE#5. THERE WAS NO PATIENT INVOLVED AND NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23060767 ↗MalfunctionSep 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
MalfunctionSep 2, 2025Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTO-FILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932212 ↗MalfunctionAug 26, 2025Inability to Auto-Fill; Gas/Air Leak; Inability to Auto-Fill; Gas/Air Leak
IT WAS REPORTED THAT DURING PLANNED INSPECTION BY FSE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD ODOMETER READING 4645 H PUMP INOPERATIVE. IT DID NOT REACH THE SET VACUUM VALUES. THERE WERE FEW TECHNICAL ERRORS GENERATED. ERROR #57, #62. THE PUMP FAILS THE FOLLOWING TESTS: AUTOFILL TEST, K6, K6A, K7, K8 LEAK TEST AND PNEUMATIC PERFORMANCE TEST. THERE WAS NO PATIENT INVOLVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22899071 ↗MalfunctionAug 14, 2025Failure to Read Input Signal; Failure to Read Input Signal
MalfunctionAug 12, 2025Failure to Read Input Signal; No Pressure; Failure to Read Input Signal; No Pressure
IT WAS REPORTED THAT CS100 INTRA AORTIC BALLOON PUMP ( IABP) SHOWED PRESSURE AND ECG PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22781721 ↗MalfunctionAug 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
MalfunctionAug 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
MalfunctionAug 1, 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 BY CUSTOMER, DURING ROUTINE CHECK CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD ELECTRICAL TEST FAILS CODE #50. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22684412 ↗MalfunctionJul 29, 2025Gas/Air Leak; Gas/Air Leak
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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