Ultraverse® 018 U8130222Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 2 mm x 220 mm, 130 cm Catheter · Class 2
All models of Ultraverse 018 (39)
Data updated Oct 16, 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 00801741054389), received between Jul 20, 2017 and Jul 20, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation 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 16, 2026.
Most reported problems
Device problems
- Inflation Problem1
- Leak/Splash1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2017Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY WOULD NOT INFLATE AND THE HEALTH CARE PROVIDER (HCP) ALLEGEDLY IDENTIFIED A LEAK AT THE TIP OF THE BALLOON. REPORTEDLY, THE HCP EXCHANGED THE BALLOON CATHETER OVER THE GUIDEWIRE FOR ANOTHER AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6730652 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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