Ultraverse® 018 U81502H30Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 2 .5 mm x 300 mm, 150 cm Catheter · Class 2
All models of Ultraverse 018 (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741064838), received between Jan 15, 2020 and Apr 20, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 Component2
- Inflation Problem1
- Packaging Problem1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2020Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U81502H30 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION PROBLEM AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9979798 ↗MalfunctionJan 15, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL, U81502H30, PTA DILATATION BALLOON CATHETER, ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR COMPONENT, AND A PACKAGING ISSUE. THIS INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES. THE MALFUNCTIONS DID NOT INVOLVE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9592075 ↗
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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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