Ultraverse® 035 PTA Dilatation Catheter U357546Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 4.0mm 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
- 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 00801741091964), received between Dec 30, 2022 and Dec 30, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Difficult to Remove1
- Entrapment of Device1
- Material Rupture1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2022Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 18 ATM. IT WAS FURTHER REPORTED THAT THE DISTAL FRAGMENT OF THE CATHETER WAS WEDGED AT THE FAV LOOP AND BECAME DETACHED. REPORTEDLY, THE DETACHED FRAGMENT WAS REMOVED SURGICALLY AND THE PATIENT EXPERIENCED PAIN AND VESSEL TRAUMA. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Perforation of Vessels
MAUDE report 16076230 ↗
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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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