VRV-II Vacuum Relief Valve 4003203Recalls & reported problems

Quest Medical Inc · Bulk, non-sterile VRV-II Vacuum Relief Valve. Contains 50 non-sterile valves. The sterile version is Model 4003103. · Class 2

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 10634624432038), received between Nov 27, 2016 and Nov 27, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Device Operates Differently Than Expected1
Infusion or Flow Problem1

Patient problems

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.

MalfunctionNov 27, 2016Device Operates Differently Than Expected; Infusion or Flow Problem
THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY THE CUSTOMER WHEN USING THE VACUUM RELIEF VALVE. THE REPORT STATED THAT THE VALVE "WOULDN'T ALLOW AIR THROUGH TO PROVIDE PRESSURE RELIEF AND BLOOD FLOW THROUGH WAS POOR". FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THEY REMOVED THE DEVICE FROM USE AND REPLACED IT WITH ANOTHER. THERE WAS NO ADDITIONAL BLOOD LOSS FROM THE USUAL THE CHANGE OUT OF VALVE PROLONGED THE PROCEDURE BY APPROXIMATELY 5 MINUTES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6128194 ↗

Device details

UDI-DI	`10634624432038`
Brand	VRV-II Vacuum Relief Valve
Model	4003203
Company	Quest Medical Inc
Product code	DWD · Suction Control, Intracardiac, Cardiopulmonary Bypass
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 13, 2019

Device type (GMDN): Cardiopulmonary bypass system valve, unidirectional flow/pressure control

A sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device.

Other Suction Control, Intracardiac, Cardiopulmonary Bypass devices

RLV-2100"B" Vacuum Relief Valve 4103202
Quest Medical Inc · Suction Control, Intracardiac, Cardiopulmonary Bypass
5 reports
VRV-II Clear Vacuum Relief Valve - Nonsterile 4004203
Quest Medical Inc · Suction Control, Intracardiac, Cardiopulmonary Bypass
4 reports

All Suction Control, Intracardiac, Cardiopulmonary Bypass devices →

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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