Ultraverse® 035 PTA Dilatation Catheter U3513074Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 7.0mm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741093678), received between Apr 15, 2020 and Dec 24, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886154 ↗MalfunctionApr 9, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED ILIAC ARTERY, THE BALLOON ALLEGEDLY RUPTURED. IT WAS SUSPECTED THAT A PIECE OF BALLOON FELL INSIDE OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641775 ↗MalfunctionApr 15, 2020Break; Break
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL U3513074, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A 64 YEAR OLD MALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9965348 ↗
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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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