Cardiovascular Procedure Kit CX-FR058Recalls & 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 00699753518841), received between Dec 11, 2025 and Dec 11, 2025 — 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

Recent adverse event reports

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

MalfunctionDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE VALVE IN THE PACK WAS LEAKING, FOUND AT THE END OF THE PROCEDURE. THERE WAS BLOOD LOSS OF APPROXIMATELY 10 MILLILITERS (ML) DURING A PEDIATRIC PROCEDURE. THERE WAS NO DELAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23783725 ↗

Device details

UDI-DI	`00699753518841`
Brand	Cardiovascular Procedure Kit
Model	CX-FR058
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 8, 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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