Ultraverse® 014 U4150215Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 2 mm x 150 mm, 150 cm Catheter · Class 2
All models of Ultraverse 014 (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741053443), received between Mar 6, 2018 and Sep 27, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM AT THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17824879 ↗MalfunctionJun 15, 2018Break; Break
IT WAS REPORTED THAT DURING PREPARATION FOR A PTA PROCEDURE, THE CATHETER ALLEGEDLY BROKE PROXIMAL TO THE BALLOON WHILE REMOVING FROM THE PACKAGING HOOP. THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7606464 ↗MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE TRYING TO LOAD THE PTA BALLOON OVER THE GUIDEWIRE THE DISTAL TIP OF THE BALLOON ALLEGEDLY DETACHED. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7317646 ↗
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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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