VIDA VDA100224Recalls & reported problems
Bard Peripheral Vascular, Inc. · VIDA™ PTV Dilatation Catheter, 22mm x 4cm, 100cm catheter · Class 2
Data updated Oct 13, 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 00801741090943), received between Aug 5, 2026 and Aug 5, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
Most reported problems
Device problems
- Inflation Problem1
- Material Deformation1
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.
MalfunctionAug 5, 2026Inflation Problem; Material Deformation
On (b)(6), 2026, a patient underwent a valvuloplasty procedure using the Vida PTV Dilatation Catheter. During the procedure, the balloon was allegedly failed to expand properly despite multiple inflation attempts, and the balloon catheter was found to be inflating asymmetrically. As no back up device was available, the procedure was abandoned. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140896 ↗
Other Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter devices
- VIDA VDA100202Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter4 reports
- VIDA VDA100126Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter1 report
- VIDA VDA100144Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter1 report
- VIDA VDA100166Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter1 report
- VIDA VDA100184Bard Peripheral Vascular, Inc. · Pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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