Cardiovascular Procedure Kit CX-SE055Recalls & 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 00699753525900), received between Oct 31, 2025 and Oct 31, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

Deformation Due to Compressive Stress1
Pressure 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.

MalfunctionOct 31, 2025Deformation Due to Compressive Stress; Pressure Problem; Deformation Due to Compressive Stress; Pressure Problem
PER CLINICAL REVIEW: THE COMPLAINT INVOLVED A TUBING PACK THAT WAS CONNECTED TO A PEDIATRIC OXYGENATOR THAT HAD A SEVERE KINK IN THE ARTERIAL TUBING LINE EXITING THE ARTERIAL PORT OF THE OXYGENATOR. THIS WAS DISCOVERED DURING INITIATION OF BYPASS. THEN THE OXYGENATION PERFORMANCE OF THE OXYGENATOR STARTED TO DECREASE, IMPACTING THE PARTIAL PRESSURE OF OXYGEN (PO2) VALUES TO DECLINE. BYPASS WAS INTERRUPTED TO CHANGE OUT THE OXYGENATOR AND TUBING PACK WITH A COMPLETE NEW SET. THERE WAS A DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM TO THE PATIENT. THE OXYGENATOR AND TUBING PACK WERE NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. A DATA LOG REVIEW WAS NOT SHARED WITH THE MANUFACTURER. PICTURES WERE TAKEN OF THE KINKED TUBING BY THE CUSTOMER DURING BYPASS AND SHARED WITH THE MANUFACTURER CONFIRMING THE KINKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437866 ↗

Device details

UDI-DI	`00699753525900`
Brand	Cardiovascular Procedure Kit
Model	CX-SE055
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 22, 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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