Ultraverse® 035 PTA Dilatation Catheter U357566Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 6.0mm x 60mm balloon, 75cm 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 00801741092961), received between May 27, 2021 and Jul 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Detachment of Device or Device Component1
- Difficult to Open or Remove Packaging Material1
- Difficult to Remove1
- Leak/Splash1
- Material Deformation1
- Material Split, Cut or Torn1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE ULTRAVERSE 035 PTA BALLOON CATHETER ALLEGEDLY HAD A CREASE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644250 ↗MalfunctionSep 15, 2023Leak/Splash; Difficult to Open or Remove Packaging Material; Material Split, Cut or Torn; Leak/Splash; Difficult to Open or Remove Packaging Material; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STYLET AND PROTECTION CAP WAS ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17754366 ↗MalfunctionMay 27, 2021Deflation Problem; Difficult to Remove; Retraction Problem; Deflation Problem; Difficult to Remove; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE AND NEEDLE STICK USED TO DEFLATE THE BALLOON. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY WAS DIFFICULT TO REMOVE FROM THE SHEATH. THERE WAS NO PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11892739 ↗
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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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