Cardiovascular Procedure Kit 64725Recalls & 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 00699753457041), received between Oct 26, 2023 and Oct 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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

Disconnection1

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 26, 2023Disconnection; Disconnection
PER CLINICAL REVIEW: THIS COMPLAINT FROM THE USER FACILITY INVOLVED THE MANUFACTURER'S PIGTAIL CONNECTION THAT BECAME DISLODGED ON A EUROSETS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR DURING ECMO (BYPASS). THE PIGTAIL WAS CONNECTED TO THE VENOUS INLET PORT OF THE OXYGENATOR. THERE WAS A 100 MILLILITER (ML) LOSS OF BLOOD TO THE PATIENT. THE CLINICIAN CLAMPED THE TUBING LINES TO STOP THE BLOOD LOSS AND STOP ECMO, SO THAT THE PIGTAIL CONNECTION COULD BE CHANGED OUT. THE PATIENT WAS ARRESTED DURING THIS TIME. ECMO WAS SUCCESSFULLY RE-INITIATED. THE PIGTAIL CONNECTION WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. A PICTURE WAS PROVIDED BY THE USER. UPON INSPECTION, THERE WERE NO VISIBLE CRACKS OR OTHER DAMAGE ON THE PIGTAIL CONNECTION. FIVE SAMPLES OF THE PIGTAIL WERE TESTED, AND NO LEAKS WERE OBSERVED. MANUFACTURING RECORDS AT THAT TIME REVEALED NO ANOMALIES. THE COMPLAINT COULD NOT BE REPLICATED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18011917 ↗

Device details

UDI-DI	`00699753457041`
Brand	Cardiovascular Procedure Kit
Model	64725
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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