Ultraverse® 035 PTA Dilatation Catheter U3513076Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 7.0mm 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741093685), received between Jan 7, 2019 and Oct 20, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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 Rupture3
- Break2
- Detachment of Device or Device Component2
- Leak/Splash1
- Material Puncture/Hole1
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN FOR USING FISTULA ANGIOPLASTY USING ULTRAVERSE 035 THE PTA BALLOON. PRIOR TO THE PROCEDURE, THE BALLOON WAS ALLEGEDLY FOUND TO BE BROKEN INTO TWO PARTS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337505 ↗MalfunctionJul 10, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE INTERIOR BOX WAS ALLEGEDLY CRUSHED AT ONE END AND SOAKED IN DETERGENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17285132 ↗MalfunctionJul 5, 2023Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY CAME WITH A SMALL HOLE AT THE JUNCTION WITH THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17257407 ↗MalfunctionJun 27, 2023Break; Material Rupture; Break; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, FRACTURE WAS ALLEGEDLY OBSERVED IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17208181 ↗MalfunctionMar 9, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DISTAL PORTION OF THE DEVICE ALLEGEDLY HAD A LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511364 ↗MalfunctionJan 7, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON OPENING THE INNER PACKAGING THE DEVICE WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8224541 ↗
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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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