Cardiovascular Procedure Kit 60045Recalls & 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 00699753453623), received between May 15, 2019 and May 15, 2019 — 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.

Most reported problems

Device problems

Fluid/Blood Leak1

Patient problems

Blood Loss1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionMay 15, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A LEAK IN THE OVER PRESSURE SAFETY (OPS) VALVE. THE CUSTOMER HAD CUT THIS OPS VALVE INTO A SUCTION LINE IN ORDER TO CONVERT IT TO VENT LINE FOR AORTIC VALVE SURGERY. THE VALVE LEAKED DURING THE CARDIOPULMONARY BYPASS SURGERY RESULTING IN APPROXIMATELY 5 ML BLOOD LOSS. THE VALVE WAS CHANGED OUT AND THERE WAS NO DELAY. SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 8613101 ↗

Device details

UDI-DI	`00699753453623`
Brand	Cardiovascular Procedure Kit
Model	60045
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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