Ultraverse® 035 PTA Dilatation Catheter U35130530Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 5.0mm x 300mm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741092756), received between Feb 27, 2018 and Apr 10, 2024 — classified as 1 injury, 2 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
- Device-Device Incompatibility1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Material Deformation1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2024Difficult to Remove; Material Rupture; Material Deformation; Difficult to Remove; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE REMOVED FROM SHEATH AFTER INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19076970 ↗InjuryFeb 19, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT AT THE COMPLETION OF AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, RESISTANCE WAS ALLEGEDLY FELT WHEN REMOVING THE GUIDEWIRE. THE PTA BALLOON AND GUIDEWIRE WERE REMOVED AS A SINGLE UNIT, WHICH RESULTED IN A TEAR AT THE ACCESS SITE THE LEFT COMMON FEMORAL ARTERY. IT WAS FURTHER REPORTED THAT THERE WAS BLEEDING AT THE ACCESS SITE, FOR ABOUT AN HOUR. THE BLEEDING WAS STOPPED WITH ASTRICTION AND NO FURTHER TREATMENT WAS NEEDED. THERE WERE NO FURTHER COMPLICATIONS TO THE PATIENT.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 8351115 ↗MalfunctionFeb 27, 2018Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT AFTER THE FIRST INFLATION, THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER USED AN INFLATION DEVICE TO OVER INFLATE THE BALLOON AND CAUSE IT TO RUPTURE. REPORTEDLY, THE BALLOON CATHETER WAS REMOVED WITHOUT INCIDENT. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7301092 ↗
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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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