Ultraverse® 035 PTA Dilatation Catheter U3513052Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 5.0mm x 20mm 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741092664), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON AUGUST 21, 2024, IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PRODUCT ALLEGEDLY HAD A DISCREPANCY IN INVOICE. IT WAS FURTHER REPORTED THAT SEVEN UNITS OF ULTRAVERSE 035 PTA CATHETER PRODUCT WAS RECEIVED OF WHICH, SIX UNITS FROM BATCH CMJQ0320 AND ONE UNIT FROM BATCH CMHT0320, BUT THE INVOICE ONLY SHOWS SEVEN UNITS FROM BATCH CMJQ0320. REPORTEDLY, THE ANVISA LABEL OF THE PRODUCT WITH BATCH CMHT0320 SHOWS BATCH CMJQ0320. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21897290 ↗
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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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