Ultraverse® 035 PTA Dilatation Catheter U3575530Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 5.0mm x 300mm 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741092534), received between Feb 25, 2022 and Feb 25, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE SUPERFICIAL FEMORAL ARTERY TO TREAT THE LOWER LIMB, THE DISTAL PART OF THE BALLOON CAUGHT ON THE SHEATH AND WAS UNABLE TO REMOVE FROM THE PATIENT AFTER DEFLATION. IT WAS FURTHER REPORTED THAT PHYSICIAN PULLED THE BALLOON FROM THE PATIENT VERY HARD WHICH CAUSED THE ARTERIAL DAMAGE. ANOTHER SHEATH WAS USED TO TAMPONADE THE DAMAGED ARTERY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13598536 ↗
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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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