Ultraverse® 035 PTA Dilatation Catheter U3513086Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 8.0mm 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741094187), received between May 23, 2022 and Sep 9, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component3
- Material Rupture3
- Adverse Event Without Identified Device or Use Problem1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE INTO TWO HALVES AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167516 ↗MalfunctionJul 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19726033 ↗InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST AN ANGIOPLASTY PROCEDURE, THE FEMORAL ARTERY, POPLITEAL ARTERY AND DORSALIS PEDIS ARTERY OF THE LEFT LOWER LIMB OF THE PATIENT ALLEGEDLY HAD NO PULSATION, A LARGE AREA OF PIEBALD-LIKE CHANGES, AND LOW SKIN TEMPERATURE. IT WAS FURTHER REPORTED THAT THROUGH DOPPLER ULTRASOUND EXAMINATION OF THE ARTERIES AND VEINS, THE PATIENT ALLEGEDLY EXPERIENCED MASSIVE THROMBOSIS IN THE ARTERIES OF THE LEFT LOWER EXTREMITY AND AN EMERGENCY ARTERIOTOMY AND EXPLORATORY THROMBECTOMY OF THE LEFT LOWER EXTREMITY ARTERIES WAS PERFORMED.. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18423776 ↗MalfunctionDec 2, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 3 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253265 ↗MalfunctionNov 4, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15732747 ↗MalfunctionMay 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY BROKE INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14521213 ↗MalfunctionMay 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY BROKE INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14467784 ↗
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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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