Ultraverse® 035 PTA Dilatation Catheter U35130625Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 6.0mm x 250mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741093241), received between May 8, 2017 and Feb 16, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (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
- Retraction Problem2
- Break1
- Deflation Problem1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient2
- Perforation of Vessels1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2026Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO REMOVE FROM THE SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Perforation of Vessels
MAUDE report 24342213 ↗MalfunctionOct 9, 2017Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE INSIDE THE 6FR SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6933130 ↗MalfunctionMay 8, 2017Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT RETRACT THROUGH THE 6 FR SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6553075 ↗
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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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