Cardiovascular Procedure Kit CX-FR256XRecalls & reported problems

Terumo Cardiovascular Systems Corporation

All models of Cardiovascular Procedure Kit (227)

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 00699753521360), received between Jan 30, 2024 and Jan 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Fluid/Blood Leak1

Patient problems

Insufficient Information1
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.

MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS A 20-MINUTE DELAY WHILE THE ENTIRE EXTRACORPOREAL CIRCUIT (CEC) WAS CHANGED OUT AND RECONDITIONED FOR THE CARDIOPULMONARY BYPASS (CPB) PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS REPORTED AN APPROXIMATELY 900 CUBIC CENTIMETER (CC) BLOOD LOSS DUE TO THE BLOOD LEFT IN THE ORIGINAL CIRCUIT WHICH REQUIRED A BLOOD TRANSFUSION FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18610587 ↗

Device details

UDI-DI	`00699753521360`
Brand	Cardiovascular Procedure Kit
Model	CX-FR256X
Company	Terumo Cardiovascular Systems Corporation
Product code	—
Class	—
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 12, 2022

Device type (GMDN): Cardiopulmonary bypass system blood tubing set

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

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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