Ultraverse® 018 U8150322Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 3 mm x 220 mm, 150 cm Catheter · Class 2
All models of Ultraverse 018 (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741064913), received between Mar 7, 2018 and Oct 8, 2024 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA RIGHT FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON COULD NOT BE SUCCESSFULLY WITHDRAWN FROM THE DELIVERY SHEATH. REPORTEDLY THE BALLOON WAS THEN PLANNED TO REMOVE OUT OF THE BODY ALONG WITH THE LONG SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396828 ↗MalfunctionMar 7, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE INNER PACKAGING LABEL REFERENCED A 2MM SIZE BALLOON AND THE OUTER PACKAGING LABEL REFERENCED A 3MM SIZE BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7321104 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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