Ultraverse® 035 PTA Dilatation Catheter U3513094Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 9.0mm x 40mm balloon, 130cm shaft · Class 2
All models of Ultraverse 035 PTA Dilatation Catheter (92)
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 00801741094460), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Difficult to Remove1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2020Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY STUCK IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10873010 ↗
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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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