Ultraverse® 014 U415054Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 5 mm x 40 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
- 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 00801741054105), received between Nov 19, 2020 and Nov 20, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Retraction Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2020Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH RIGHT FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD RETRACTION ISSUE AND DETACHED FROM THE SHAFT. THE PHYSICIAN USED ANOTHER DEVICE TO RETRIEVE THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10873243 ↗MalfunctionNov 19, 2020Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE RIGHT FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD RETRACTION ISSUE AND DETACHED FROM THE SHAFT. ANOTHER DEVICE WAS USED TO RETRIEVE THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10866635 ↗
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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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