Ultraverse® 014 U41502H4Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 2.5 mm x 40 mm, 150 cm Catheter · Class 2
All models of Ultraverse 014 (36)
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 00801741053504), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionAug 30, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED DURING FIRST INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15318719 ↗
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- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
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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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