Ultraverse® 014 U4150322Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 3 mm x 220 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741053832), received between Oct 27, 2020 and Oct 24, 2022 — classified as 4 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Device Damaged Prior to Use1
- Leak/Splash1
- Material Rupture1
- Packaging Problem1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2022Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A LEAK IN THE CONNECTION OF THE SHAFT WITH THE INFLATION PORT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657013 ↗MalfunctionDec 1, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED DURING FIRST INFLATION ATTEMPT AT 8ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10926492 ↗MalfunctionNov 9, 2020Unraveled Material; Device Damaged Prior to Use; Unraveled Material; Device Damaged Prior to Use
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE THE PTA BALLOON MATERIAL ALLEGEDLY UNRAVELED THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10808063 ↗MalfunctionOct 27, 2020Packaging Problem; Packaging Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150322 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PACKAGING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10743898 ↗
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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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