NAVICROSS NC35900Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350709264), received between Jun 19, 2018 and Jun 27, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (3 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.

• InjuryJun 27, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT TWO OF THE NAVICROSS RADIOPAQUE MARKERS CAME OFF THE DEVICE DURING USE AND REMAINED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 3, 2019. PER HEALTH (B)(6) REPORT ((B)(4)): "DURING PROCEDURES ENDOVASCULAR FOR (ILIAC STENTING) TWO SEPARATE RADIO OPAQUE MARKERS CAME OFF, TWO DIFFERENT NAVICROSS SUPPORT CATHETERS INTO THE PATIENT." ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2019. THE INCIDENT WAS REGARDING TWO NAVICROSS CATHETERS TO THE SAME PATIENT. NO SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT FOR THE RADIO OPAQUE MARKERS. AFTER THE SECOND NAVICROSS CATHETER LOST ITS RADIO OPAQUE MARKERS, THEY SWITCHED TO A DIFFERENT PRODUCT. A COOK MEDICAL J-WIRE, GUIDE WIRE OR BENSON WIRE WAS BEING USED ALONG WITH THE NAVICROSS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8740883 ↗
• InjuryJun 27, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT TWO OF THE NAVICROSS RADIOPAQUE MARKERS CAME OFF THE DEVICE DURING USE AND REMAINED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 3, 2019. PER HEALTH CANADA REPORT ((B)(4)): "DURING PROCEDURES ENDOVASCULAR FOR (ILIAC STENTING) TWO SEPARATE RADIO OPAQUE MARKERS CAME OFF, TWO DIFFERENT NAVICROSS SUPPORT CATHETERS INTO THE PATIENT." ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 26, 2019. THE INCIDENT WAS REGARDING TWO NAVICROSS CATHETERS TO THE SAME PATIENT. NO SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT FOR THE RADIO OPAQUE MARKERS. AFTER THE SECOND NAVICROSS CATHETER LOST ITS RADIO OPAQUE MARKERS, THEY SWITCHED TO A DIFFERENT PRODUCT. A COOK MEDICAL J-WIRE, GUIDE WIRE OR BENSON WIRE WAS BEING USED ALONG WITH THE NAVICROSS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8740882 ↗
• InjuryJun 19, 2018Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED JUNE 25, 2018. THE GOLD MARKER WAS NOT REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7614768 ↗