CS300 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL 0998-UC-3023-67Recalls & reported problems

Datascope Corp. · CS300 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10607567108810), received between Oct 20, 2023 and Oct 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inability to Auto-Fill” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Inability to Auto-Fill1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 20, 2023Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17977350 ↗

Device details

UDI-DI	`10607567108810`
Brand	CS300 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL
Model	0998-UC-3023-67
Company	Datascope Corp.
Product code	DSP · System, Balloon, Intra-Aortic And Control
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 6, 2021

Device type (GMDN): Intra-aortic balloon pump

An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.

Other System, Balloon, Intra-Aortic And Control devices

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SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01
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20 recalls3 deaths456 reports

All System, Balloon, Intra-Aortic And Control devices →

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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