NAVICROSS NC35130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350709288), received between Feb 12, 2020 and Jun 11, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED NAVICROSS WAS USED DURING THE PROCEDURE. THE CATHETER WAS OPENED AND WAS BEING ADVANCED OVER A GLIDEWIRE ADVANTAGE .035 WHEN IT WAS NOTICED THAT IT WAS KINKED SO BADLY THAT IT WOULD NOT GO OVER THE WIRE; IT WAS ALMOST SEVERED. IT WAS STRAIGHT OUT OF THE BOX. A DIFFERENT CATHETER WAS SELECTED, AND THE CASE PROCEEDED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142808 ↗
• MalfunctionFeb 12, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE NAVICROSS CATHETER BROKE. THE PATIENT'S CONDITION AND PROCEDURE OUTCOME WERE NOT AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 05FEB2020. NONE OF THE BROKEN CATHETER WAS LEFT IN THE PATIENT. TO REMOVE THE WIRE, IT WAS PULLED BACK. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS A LEG REVASCULARIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699910 ↗