Ultraverse® 018 U81502H15Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 2 .5 mm x 150 mm, 150 cm Catheter · Class 2
All models of Ultraverse 018 (39)
Data updated Oct 18, 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 00801741064814), received between Apr 21, 2021 and Dec 25, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Break1
- Deflation Problem1
- Difficult to Advance1
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 25, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA LEFT COMMON ILIAC ARTERY, AFTER DILATATION, IT WAS FOUND THAT THE BALLOON ALLEGEDLY COULD NOT BE RETRIEVED, AND THE BALLOON WAS WITHDRAWN FROM THE BODY AFTER EXTRACORPOREAL PUNCTURE OF THE BALLOON WITH A MICRO PENETRATING NEEDLE UNDER THE CONTRAST MEDIUM WAS PERFORMED TO RELIEVE THE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21014823 ↗MalfunctionJul 20, 2021Material Rupture; Device-Device Incompatibility; Difficult to Advance; Material Rupture; Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE ON LEFT FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO PASS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12194554 ↗MalfunctionApr 21, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH RIGHT FEMORAL ARTERY FOR THE TREATMENT OF ATHEROSCLEROTIC OCCLUSION, THE PTA BALLOON ALLEGEDLY UNABLE TO PASS THROUGH GUIDE WIRE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11699407 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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