NUVISION Ultrasound Catheter FG12080Recalls & reported problems
Biosense Webster Inc · NUVISION ICE CATHETER, 10F · Class 2
Data updated Oct 18, 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 10846835026566), received between Feb 17, 2026 and Aug 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem1
- Display or Visual Feedback Problem1
- Overheating of Device1
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.
MalfunctionAug 30, 2026Display or Visual Feedback Problem; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512286 ↗MalfunctionFeb 17, 2026Overheating of Device
IT WAS REPORTED THAT A PATIENT UNDERWENT AN LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE WITH A NUVISION NAV ULTRASOUND CATHETER AND AN OVERHEATING ISSUE WAS OBSERVED. THE S70 ULTRASOUND MACHINE DISPLAYED AN ERROR THAT INDICATED THE CATHETER WAS OVERHEATING AND IT INSTRUCTED TO RESELECT THE CATHETER. RESEATED THE CATHETER WITHOUT RESOLUTION. RESELECTED THE CATHETER WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED. NO ABLATION WAS COMPLETED DURING THIS PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368826 ↗
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- OptiCross™ HD H74939352040Boston Scientific Corporation · Catheter, ultrasound, intravascular3 deaths116 reports
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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