Skip to content

VIDA VDA100166Recalls & reported problems

Bard Peripheral Vascular, Inc. · VIDA™ PTV Dilatation Catheter, 16mm 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 00801741090875), received between Sep 5, 2023 and Sep 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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.

Most reported problems

Device problems

  • 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.

  • MalfunctionSep 5, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY BURST WHEN INFLATED AT 16 ATM POST DILATING A STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17681039 ↗

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

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.