NUVISION NAV Ultrasound Catheter FG12081Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835026559), received between Dec 15, 2025 and Mar 16, 2026 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NUVISION ULTRASOUND CATHETER AND THE PROBE WAS OVERHEATING. A WARNING DISPLAYED, INDICATING IT WAS GETTING TOO HOT, IT FROZE AND THEN CUT OFF. THE CATHETER AND CABLE WERE RESEATED WITHOUT RESOLUTION. THE SWIFTLINK WAS RESEATED WITHOUT RESOLUTION. THE CATHETER WOULD COOL, AND WHEN TURNED BACK ON THE ISSUE REPEATED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607574 ↗
• MalfunctionJan 20, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A NUVISION NAV ULTRASOUND CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE TIP AREA. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN CONNECTING THE NUVISION NAV CATHETER, THE S70 ULTRASOUND MACHINE HAD A RED ERROR "PROBE NOT RECOGNIZED". NO ERRORS ON THE CARTO 3 SYSTEM. THE CATHETER CONNECTIONS WERE RESEATED, AND DIFFERENT PORTS WERE USED, WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED AND COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED RECOGNITION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE TIP AREA. THE FINDING WAS REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127304 ↗
• MalfunctionDec 15, 2025Pumping Stopped

  CATHETER ENTERED THE BODY, WORKED FOR THE MAJORITY OF THE CASE. THEN IT FROZE AND WOULD NOT UNFREEZE. MD REQUESTED DIFFERENT BRAND ICE CATHETER. PROBLEM SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802470 ↗