Ultraverse® 014 U415028Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 2 mm x 80 mm, 150 cm Catheter · Class 2
All models of Ultraverse 014 (36)
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 00801741053351), received between Apr 15, 2019 and Apr 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or 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 or Device Component1
- Retraction Problem1
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.
MalfunctionApr 15, 2019Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE INFORMATION INDICATED THAT MODEL U415028 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DIFFICULTIES BEING RETRACTED ACROSS THE LESION SITE AND CATHETER DETACHMENT. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCE. OF THE ONE REPORTED MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8516331 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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