Ultraverse® 018 U8150315Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 3 mm x 150 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 00801741064906), received between Oct 10, 2023 and Oct 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Dislodged or Dislocated1
- Device-Device Incompatibility1
- Difficult to Remove1
- Failure to Advance1
- Material Deformation1
- Material Rupture1
- Material Twisted/Bent1
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.
MalfunctionOct 8, 2024Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation; Material Twisted/Bent; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE COMMON FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY CAN NO LONGER BE RETRACTED IN THE BLOOD VESSEL. REPORTEDLY, THE SURGEON CHOOSES TO WITHDRAW THE BALLOON AND GUIDEWIRE AS A WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20394236 ↗MalfunctionOct 10, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA ANTEGRADE APPROACH THROUGH THE LEFT FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY LEAKED CONTRAST MEDIUM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED OUT OF THE PATIENT AND RUPTURE WAS FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17903398 ↗
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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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