VIDA VDA100126Recalls & reported problems

Bard Peripheral Vascular, Inc. · VIDA™ PTV Dilatation Catheter, 12mm x 6cm, 100cm catheter · Class 2

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 00801741090813), received between Jan 16, 2024 and Jan 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Deformation1
Material Rupture1

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.

MalfunctionJan 16, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18516147 ↗

Device details

UDI-DI	`00801741090813`
Brand	VIDA
Model	VDA100126
Company	Bard Peripheral Vascular, Inc.
Product code	OMZ · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
Class	Class 2
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	Mar 29, 2018

Device type (GMDN): Cardiac valvuloplasty catheter

A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

Other Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter devices

VIDA VDA100202
Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
4 reports
VIDA VDA100144
Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
1 report
VIDA VDA100166
Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
1 report
VIDA VDA100184
Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
1 report
VIDA VDA100224
Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
1 report

All Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.