Ultraverse® 035 PTA Dilatation Catheter U3575515Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 5.0mm x 150mm 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 00801741092503), received between Jan 13, 2017 and Jan 15, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (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.
Most reported problems
Device problems
- Retraction Problem3
- Deflation Problem1
- Detachment of Device or Device Component1
- Kinked1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U3575515 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT, AND FAILURE TO RETRACT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9594150 ↗MalfunctionFeb 16, 2017Retraction Problem; Retraction Problem
IT WAS REPORTED THAT FOLLOWING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY COULD NOT BE RETRACTED THROUGH THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED AS A SINGLE UNIT AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6337543 ↗MalfunctionJan 13, 2017Deflation Problem; Kinked; Retraction Problem; Deflation Problem; Kinked; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE FEMORAL ARTERY THE PTA BALLOON ALLEGEDLY COULD NOT BE DEFLATED AFTER THE FIRST INFLATION. REPORTEDLY, THE BALLOON AND SHEATH WERE REMOVED AS A SINGLE UNIT. MANUAL PRESSURE AT THE INCISION SITE AND COMPRESSING DRESSING WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6251324 ↗
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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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