Ultraverse® 018 U820084Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 8 mm x 40 mm, 200 cm Catheter · Class 2
All models of Ultraverse 018 (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741165108), received between Jun 15, 2023 and Jun 15, 2023 — classified as 1 death.
The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
- Material Deformation1
Patient problems
- Cardiac Arrest1
- Cardiovascular Dysfunction/Insufficiency1
- Ventricular Fibrillation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 15, 2023Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A BALLOON WAS USED IN A PATIENT AFTER BEING DIAGNOSED WITH HYPERTENSION, CACHEXIA, UNSTABLE ANGINA, AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY LESION. MULTIPLE BALLOONS WERE USED TO PLACE THE STENT AND AT SOME TIME POST THE STENT DEPLOYMENT, THE PATIENT WAS DECEASED DUE TO THE CARDIAC ARREST, POST PERCUTANEOUS CORONARY INTERVENTION VENTRICULAR FIBRILLATION ARREST AND THE HEART FAILURE. THERE WERE NO BALLOON RELATED TECHNICAL DIFFICULTIES IDENTIFIED WITHIN THE PROVIDED MEDICAL RECORDS. THE PATIENT WAS REPORTEDLY EXPIRED.
Patient problems: Cardiac Arrest; Cardiovascular Dysfunction/Insufficiency; Ventricular Fibrillation
MAUDE report 17132887 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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