Ultraverse® 035 PTA Dilatation Catheter U3513078Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 7.0mm x 80mm 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
- 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 00801741093692), received between Jul 29, 2020 and Jul 29, 2020 — 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
- Retraction Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE THROUGH LEFT HUMERAL ARTERY IN LEFT EXTERNAL ILIAC ARTERY, THE DEVICE ALLEGEDLY HAD RETRACTION PROBLEM. IT WAS FURTHER REPORTED MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS STABLE.
Patient problems: Injury
MAUDE report 10337993 ↗
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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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