Ultraverse® 035 PTA Dilatation Catheter U3513046Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 4.0mm x 60mm 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 00801741092183), received between Nov 10, 2020 and Nov 10, 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
- Inflation Problem1
- Leak/Splash1
- Material Deformation1
- Material Puncture/Hole1
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 10, 2020Inflation Problem; Leak/Splash; Material Puncture/Hole; Difficult to Remove; Material Deformation; Inflation Problem; Leak/Splash; Material Puncture/Hole; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY, THE LEAKAGE WAS IDENTIFIED IN THE BODY OF THE BALLOON. IT WAS FURTHER REPORTED THAT THE DEVICE HAD DIFFICULTY TO REMOVING AND NOT POSSIBLE TO INFLATE AGAIN. UPON REMOVING NOTICED IT HAD GROOVES IN BODY AND HAD A HOLE IN DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10814979 ↗
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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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