Ultraverse® 018 U8150530Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® 018 PTA Balloon Dilatation Catheter 5 mm x 300 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 00801741065194), received between Jun 13, 2025 and Apr 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
- Inflation Problem1
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.
MalfunctionApr 13, 2026Inflation Problem; Device Contamination with Chemical or Other Material
On (b)(6)2026, a 48-year-old male patient underwent a percutaneous transluminal angioplasty (PTA) procedure using the Ultraverse 018 balloon catheter. During the procedure, the balloon catheter allegedly unable to inflate and the particles came from inside of the balloon. The procedure was completed using another balloon. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24856074 ↗MalfunctionJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON CATHETER VIA COMMON FEMORAL CONTRALATERAL APPROACH. DURING THE PROCEDURE, THE MARKER ON THE CATHETER BALLOON WAS ALLEGEDLY OFF A CENTIMETER OR TWO. IT WAS FURTHER REPORTED THAT THE BALLOON INFLATED BEYOND THE MARKER. BALLOON WAS REMOVED, AND ANGIOGRAM WAS PERFORMED TO VERIFY NO INJURY TO THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201310 ↗
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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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