Ultraverse® 014 U4100222Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 2 mm x 220 mm, 100 cm Catheter · Class 2
All models of Ultraverse 014 (36)
Data updated Oct 16, 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 00801741053450), received between Jan 16, 2020 and Jan 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Packaging Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2020Break; Packaging Problem; Break; Packaging Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4100222 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND PACKAGING ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9598086 ↗
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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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