Ventricular vent catheter VT-xxxxx (UDI 00803622106378)Recalls & reported problems

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 00803622106378), received between Nov 7, 2017 and Nov 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

Detachment Of Device Component1

Patient problems

No Consequences Or Impact 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 7, 2017Detachment Of Device Component; Detachment Of Device Component
LIVANOVA RECEIVED A REPORT THAT THE VENT VALVE OF THE MALLEABLE VENT CATHETER SEPARATED FROM THE DEVICE DURING A PROCEDURE. THE DEVICE WAS CHANGED OUT WITHOUT DELAY AS SOON AS THE ISSUE WAS DETECTED. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7008450 ↗

Device details

UDI-DI	`00803622106378`
Brand	Ventricular vent catheter
Model	VT-xxxxx
Company	Livanova USA, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K981601
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 15, 2018

Device type (GMDN): Heart ventricle cannula

A sterile, rigid or semi-rigid tube designed to be surgically inserted into a cardiac ventricle. This is typically done directly during a surgical procedure and advanced until its distal tip is inside the cardiac ventricle. This device will serve as a channel intended for connection to an external device, such as left or right ventricular assist system. Some types may be used for temporary decompression of the left ventricle. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.

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All CATHETER, CANNULA AND TUBING, VASCULAR, 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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