NAVICROSS NC35650Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350709240), received between Jul 17, 2019 and Jul 17, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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.

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.

• InjuryJul 17, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE NAVICROSS CATHETER KEPT GETTING STUCK IN SEVERE CALCIUM IN THE HUNTER'S CANAL. THE CATHETER WAS BEING USED IN CONJUNCTION WITH A CROSPERIO THROUGH PEDAL ACCESS. THE BALLOON WAS INFLATED AND THE BALLOON HAD SOMETHING CONSTRICTING IT IN THE MIDDLE PORTION. WHEN THE CATHETER WAS PULLED BACK, IT APPEARED THAT THE OUTER COATING WAS PULLED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 28, 2019. THE PROCEDURE WAS AN ENDOVASCULAR REVASCULARIZATION SFA OCCLUSION - CTO; LONG SEGMENT OCCLUSION. THE TIP OF THE NAVICROSS BROKE OFF AT THE FIRST RING WITH THE BRIGHT TIP MARKER AND WAS RETRIEVED WITH A BALLOON. THERE WAS NO PIECE LEFT IN THE PATIENT. THE PATIENT CONDITION WAS REPORTED TO BE FINE AFTER THE PROCEDURE. THERE WAS BLOOD LOSS IN THE AMOUNT OF 50CC.

  Patient problems: Blood Loss

  MAUDE report 8800514 ↗
• InjuryJul 17, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE NAVICROSS CATHETER KEPT GETTING STUCK IN SEVERE CALCIUM IN THE HUNTER'S CANAL. THE CATHETER WAS BEING USED IN CONJUNCTION WITH A CROSPERIO THROUGH PEDAL ACCESS. THE BALLOON WAS INFLATED AND THE BALLOON HAD SOMETHING CONSTRICTING IT IN THE MIDDLE PORTION. WHEN THE CATHETER WAS PULLED BACK, IT APPEARED THAT THE OUTER COATING WAS PULLED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 28, 2019. THE PROCEDURE WAS AN ENDOVASCULAR REVASCULARIZATION SFA OCCLUSION - CTO; LONG SEGMENT OCCLUSION. THE TIP OF THE NAVICROSS BROKE OFF AT THE FIRST RING WITH THE BRIGHT TIP MARKER AND WAS RETRIEVED WITH A BALLOON. THERE WAS NO PIECE LEFT IN THE PATIENT. THE PATIENT CONDITION WAS REPORTED TO BE FINE AFTER THE PROCEDURE. THERE WAS BLOOD LOSS IN THE AMOUNT OF 50CC.

  Patient problems: Blood Loss

  MAUDE report 8800512 ↗