NAVICROSS NC35151Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350709226), received between Nov 22, 2016 and Sep 28, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2021Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "WHILE LOADING NAVICROSS SUPPORT CATHETER ONTO WIRE, TIP BROKE OFF. THE NAVICROSS SUPPORT CATHETER WAS REMOVED, AND DID NOT ENTER PATIENT." THE INTENDED PROCEDURE WAS A CARDIAC CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUL2021. WHEN THE SUPPORT CATHETER TIP BROKE OFF AND WAS REMOVED, TO CONTINUE THE CARDIAC CATHETERIZATION FOR THE PATIENT A SECOND NAVICROSS WAS USED. OPERATIVE REPORT REFERS TO ADVANTAGE WIRE WAS USED WITH THE REPORTED DEVICE, NO SIZE MENTIONED. THERE WAS NO REPORTED BLOOD LOSS. THE PATIENT WAS STABLE AT TIME OF DISCHARGE. ADDITIONAL INFORMATION WAS RECEIVED ON 15SEP2021. THIS WAS USED DURING ORBITAL ATHERECTOMY AND BALLOON ANGIOPLASTY OF THE RIGHT SFA. HERE IS THE PROCEDURE DESCRIPTION: INDICATIONS: A 90% STENOSIS OF THE RIGHT SFA HEAVILY CALCIFIED SEGMENT. RUTHERFORD CLASS 3. DESCRIPTION OF PROCEDURE: AFTER OBTAINING INFORMED CONSENT, THE PATIENT WAS BROUGHT INTO THE CATH LAB. SHE WAS PREPPED AND DRAPED TO OBTAIN A STERILE FIELD. THE LEFT GROIN WAS ANESTHETIZED WITH 1% LIDOCAINE. THE LEFT COMMON FEMORAL ARTERY WAS CANNULATED USING MODIFIED SELDINGER TECH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541157 ↗
• InjuryAug 4, 2021Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # 0300360000-2021-8015. THE EVENT DESCRIPTION STATES: "WHILE LOADING NAVICROSS SUPPORT CATHETER ONTO WIRE, TIP BROKE OFF. THE NAVICROSS SUPPORT CATHETER WAS REMOVED, AND DID NOT ENTER PATIENT." THE INTENDED PROCEDURE WAS A CARDIAC CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUL2021. WHEN THE SUPPORT CATHETER TIP BROKE OFF AND WAS REMOVED, TO CONTINUE THE CARDIAC CATHETER ERIZATION FOR THE PATIENT A SECOND NAVICROSS WAS USED. OPERATIVE REPORT REFERS TO ADVANTAGE WIRE WAS USED WITH THE REPORTED DEVICE, NO SIZE MENTIONED. THERE WAS NO REPORTED BLOOD LOSS. THE PATIENT WAS STABLE AT TIME OF DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274754 ↗
• InjuryNov 22, 2016Break; Break

  THE USER FACILITY REPORTED THE MARKER CAME OF THE DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DISTAL MARKER OF THE NAVICROSS CAME OFF IN THE PATIENT'S SFA; IT WAS RETRIEVED WITH A SNARE; THE PROCEDURE WAS COMPLETED; AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6122536 ↗