Cardiovascular Procedure Kit 73957-02Recalls & 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 00699753507012), received between Nov 20, 2023 and Nov 20, 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Air/Gas in Device1
Leak/Splash1

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.

MalfunctionNov 20, 2023Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device
PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED A CP50 CARDIOPLEGIA DELIVERY UNIT THAT LEAKED DURING CARDIOPULMONARY BYPASS. THE LEAK OCCURRED AROUND THE TEMPERATURE THERMISTOR LOCATED ON THE OUTFLOW PORT OF THE CP50 UNIT. THE CP50 UNIT WAS CHANGED OUT. THERE WAS A LOSS OF APPROXIMATELY 200CC OF BLOOD. THE CP50 UNIT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. UPON INSPECTION, THE LEAK WAS CONFIRMED ON THE COMPLAINT UNIT. THE MANUFACTURING RECORDS AT THAT TIME REVEALED NO ANOMALIES IN PRODUCTION. THE MOST LIKELY CAUSE WAS WORKMANSHIP ERROR, POSSIBLY AS A RESULT OF A LOOSE THERMISTOR BEING RE-TIGHTENED BY PRODUCTION ASSOCIATES AND THEN BEING SUBJECTED TO STRESS DURING HEAT STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18172664 ↗

Device details

UDI-DI	`00699753507012`
Brand	Cardiovascular Procedure Kit
Model	73957-02
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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