Cardiovascular Procedure Kit 74460-01Recalls & 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 00699753490048), received between May 26, 2023 and May 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (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

Air/Gas in Device1
Human-Device Interface Problem1

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.

MalfunctionMay 26, 2023Human-Device Interface Problem; Air/Gas in Device; Human-Device Interface Problem; Air/Gas in Device
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), AIR WAS INADVERTENTLY DELIVERED TO THE PATIENT. THE TEAM WAS UNFAMILIAR WITH A SUBSTITUTION CARDIOVASCULAR PROCEDURE KIT USED DURING AN EMERGENCY CASE AND AS THE SUCKER LINE PRESSURE WAS INCREASED DUE TO A SMALLER DIAMETER SUCKER LINE, AIR WAS INADVERTENTLY DELIVERED TO THE PATIENT. AS MITIGATION, THE SUCKER LINE WAS IMMEDIATELY SHUT OFF. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY OF ABOUT 20 MINUTES. THERE WAS NO BLOOD LOSS BUT THERE WERE ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED A CUSTOM PEDIATRIC PERFUSION TUBING PACK THAT WAS ALSO USED AS A SUBSTITUTE FOR AN UNAVAILABLE PEDIATRIC PERFUSION TUBING PACK FOR THE USER FACILITY. THE SUBSTITUTE TUBING PACK ITSELF DID NOT HAVE ANY DEFECTS OR DYSFUNCTIONAL PERFORMANCE ISSUES IN THIS BYPASS CASE. AN FX05 PEDIATRIC OXYGENATOR WAS ALSO USED. A 3-YEAR-OLD PATIENT UNDERGOING A FONTAN PROCEDURE WAS INADVERTENTLY SUBJECTED TO AN AIR EMBOLISM THROUGH THE PERFUSION CIRCUITRY. THE PATIENT SUFFERED A POST-OP SEIZURE. THE PATIENT WAS SUBJECTED TO SEVERAL POST-OP DIAGNOSTIC TESTS, AND IT WAS DETERMINED TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17011567 ↗

Device details

UDI-DI	`00699753490048`
Brand	Cardiovascular Procedure Kit
Model	74460-01
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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