Ultraverse® 035 PTA Dilatation Catheter U351301010Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 10.0mm x 100mm 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 00801741094736), received between Nov 7, 2023 and Nov 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Device-Device Incompatibility1
- Difficult to Insert1
- Difficult to Remove1
- Failure to Advance1
- Material Deformation1
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 7, 2023Difficult to Insert; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY VIA THE FEMORAL ARTERY APPROACH, THE JOINT OF THE BALLOON AND THE DELIVERY SYSTEM WAS ALLEGEDLY MISLOCATED, AND THE JOINT WAS ALLEGEDLY DEFORMED. IT WAS FURTHER REPORTED THAT DUE TO MISLOCATION, THERE WAS OBSTRUCTION OF THE GUIDE WIRE PASSING AND THE GUIDEWIRE ALLEGEDLY GOT STUCK IN THE SHEATH, AND WAS UNABLE TO BE ADVANCED. FURTHERMORE, THE CATHETER WAS ALLEGEDLY DIFFICULT TO BE REMOVED, AND EVENTUALLY THE CATHETER AND SHEATH WERE WITHDRAWN TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18083359 ↗
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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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