CS300 Intra-Aortic Balloon Pump, English, 220V 0998-00-3023-55Recalls & reported problems
Datascope Corp. · CS300 Intra-Aortic Balloon Pump, English, 220V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Datascope CS300 intra-aortic balloon pump is the subject of 1,040 adverse event reports, which mention 2 deaths and 1 injury. Many reports describe the pump not powering up, battery problems, failed auto-fill and incorrect messages. Reports fell from 213 in the previous 12 months to 86 in the latest 12 months. 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
- 1,062
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,062 adverse event reports that list this exact device (DI 10607567112541), received between Aug 26, 2020 and Sep 29, 2026 — classified as 2 deaths, 1 injury, 1,059 malfunctions.
The most frequently reported specific device problem is “Inability to Auto-Fill” (117 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 Available127
- Inability to Auto-Fill117
- Battery Problem109
- Failure to Power Up83
- Device Displays Incorrect Message58
- Electrical /Electronic Property Problem57
- Incorrect, Inadequate or Imprecise Result or Readings56
- Failure to Sense48
Patient problems
- No Clinical Signs, Symptoms or Conditions1,022
- Insufficient Information131
- No Patient Involvement15
- No Known Impact Or Consequence To Patient7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- No Consequences Or Impact To Patient5
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 1,062 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928275 ↗MalfunctionSep 28, 2026Power Problem
It was reported by the customer that during routine check, the CS300 Intra-Aortic Balloon Pump (IABP) was not turning on. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE checked the unit and found that the Power Supply was defective and needed to be replaced. After the Power Supply was replaced, the machine operated correctly. Product passed all functional and safety tests per manufacturer specifications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912984 ↗MalfunctionSep 28, 2026Calibration Problem; Unexpected Shutdown
It was reported by the customer that during a routine check, the CS300 Intra-Aortic Balloon Pump (IABP) is displaying an error message "system failure". There was no patient involvement. No harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed that they found the machine showing the "System failure" error. The FSE replaced the Main Board and then the device was showing Error Code 5 (Maintenance Required # 5 - Helium Pressure Transducer Out of Calibration). The required Helium Tank calibration was performed. Product passed all functional and safety tests per manufacturer specifications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912905 ↗MalfunctionSep 24, 2026Device Alarm System; Battery Problem; Power Problem
It was reported by the customer that during routine check, the CS300 Intra-Aortic Balloon Pump (IABP) had no battery back up. There was no patient involvement, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that unit drained batteries immediately, after replacing batteries additional low battery alarm was present. Power supply Board was found to be suspected and it needs to be replaced for further diagnostics.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878046 ↗MalfunctionSep 24, 2026Battery Problem; Power Problem
It was reported by FSE that during Preventive Maintenance the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. No patient involved. No harm reported. The FSE reported that machine is not working on battery. Battery was replaced. During evaluation it was also found out that power supply is defective and needs to be replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877585 ↗MalfunctionSep 23, 2026Battery Problem
It was reported by the customer that during a routine check, the CS300 Intra-Aortic Balloon Pump (IABP) displayed a ¿Low Battery¿ message and had insufficient battery backup. There was no patient involvement and no harm reported. A Getinge Field Service Engineer (FSE) evaluated the unit. During the evaluation, the device was tested after disconnecting it from AC power and was found to switch off within approximately one minute. The FSE determined that the battery was defective and was not providing adequate backup power. The battery requires replacement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867290 ↗MalfunctionSep 23, 2026Inability to Auto-Fill
It was reported by the FSE that during PM, the CS300 Intra-Aortic Balloon Pump (IABP) had Autofill Failure. There was no patient involved, no harm reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirmed the Autofill Failure in device logs. The device is currently pending a repair.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866532 ↗MalfunctionSep 21, 2026Electrical /Electronic Property Problem
It was reported that during routine check by customer the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. Electrical test fail code 50 has been reported by distributor's Field Service Engineer (FSE). No harm reported. No patient involvement reported. The Getinge FSE was dispatched to evaluate the unit. It was reported that motor control PCB was found to be defective and it was replaced. Electrical Test confirmed in logs attached. Safe for clinical use and can be released to the users. Product passed all functional and safety tests per manufacturer specifications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835646 ↗MalfunctionSep 18, 2026No Display/Image; Charging Problem; Power Problem
It was reported by FSE that during machine repair, the CS300 Intra-Aortic Balloon Pump (IABP) power supply is faulty. The battery that was previously replaced for a customer was found to be faulty - battery is not charging. The device screen remained white all the time and could not display anything. There was no patient involvement. No harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that power supply was replaced. After that screen remain white and is not display anything. The machine is not functioning normally.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814116 ↗MalfunctionSep 17, 2026Gas/Air Leak
It was reported by the customer that during a routine check the CS300 Intra-Aortic Balloon Pump (IABP) had a helium leak. No patient was involved. No harm was reported. Pending acceptance of repair from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800702 ↗MalfunctionSep 17, 2026No Display/Image; Electrical /Electronic Property Problem
It was reported by the customer that during routine check the CS300 Intra-Aortic Balloon Pump (IABP) failed electrical test #50 and display was not visible. No patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE reported that they checked the machine and found the issue with Inverter PCB and Motor control PCB. The FSE replaced both the parts. Product passed all functional and safety tests per manufacturer specifications. Handed over the machine in good working condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800143 ↗MalfunctionSep 17, 2026Electrical /Electronic Property Problem; Failure to Read Input Signal
It was reported that during a routine check the CS300 Intra-Aortic Balloon Pump (IABP) electrical test fails 39 and electrical test fails 65 occurred. No patient involved. No harm was reported. The issue discovered by the customer. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. The FSE confirm that the eletrical faile codes occurred. Board is suspected to be defective. After the replacement of main board, errors 39 and 65 no longer appeared. After further testing a machine exhibited A.P. Optical Sensing Module Failure. Fiber Optic Sensor Module (FOS) is suspected to be defective and needs to be replaced. After replacement of FOS module machine is working properly and was handed to user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800045 ↗MalfunctionSep 17, 2026Alarm Not Visible
It was reported by the Field Service Engineer that, the CS300 Intra-Aortic Balloon Pump (IABP) is showing battery backup low. There was no information about patient involvement. No harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50798463 ↗MalfunctionSep 16, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50784934 ↗MalfunctionSep 16, 2026Alarm Not Visible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50783740 ↗MalfunctionSep 2, 2026Inability to Auto-Fill; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567425 ↗MalfunctionSep 2, 2026Device Contamination with Body Fluid
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559082 ↗MalfunctionSep 2, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558915 ↗MalfunctionSep 1, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541178 ↗MalfunctionAug 31, 2026Failure to Power Up
It was reported by customer that during a routine check the CS300 Intra-Aortic Balloon Pump (IABP) malfunctioned. Device not turning on has been reported. There was no patient involvement and no harm was reported. A Getinge Field Service Engineer (FSE) was dispatched to evaluate the unit. During the evaluation, the FSE determined that no data was displayed on the screen and identified the power supply assembly as defective. The power supply assembly requires replacement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518404 ↗MalfunctionAug 24, 2026Failure to Power Up
MalfunctionAug 23, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50393666 ↗MalfunctionAug 19, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323203 ↗MalfunctionAug 4, 2026Failure to Deflate
MalfunctionAug 3, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113666 ↗
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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