NAVICROSS NC35901Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04987350709189), received between Sep 11, 2018 and Feb 10, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Material Separation; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PRODUCT WAS USED DURING A TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WITH A NAVICROSS CATHETER OVER A 0.035'' AMPLATZ WIRE TO ACCESS THE PORTAL VEIN. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE DISTAL TAPERED TIP OF THE NAVICROSS CATHETER BECAME LODGED. UPON FURTHER RETRACTION, THE CATHETER SEPARATED AT THE DISTAL END. THIS EVENT OCCURRED OUTSIDE THE PATIENT, AND THE DETACHED SEGMENT WAS RETRIEVED WITHOUT COMPLICATION. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24304904 ↗
• InjuryFeb 10, 2026Material Separation; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PRODUCT WAS USED DURING A TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WITH A NAVICROSS CATHETER OVER A 0.035'' AMPLATZ WIRE TO ACCESS THE PORTAL VEIN. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE DISTAL TAPERED TIP OF THE NAVICROSS CATHETER BECAME LODGED. UPON FURTHER RETRACTION, THE CATHETER SEPARATED AT THE DISTAL END. THIS EVENT OCCURRED OUTSIDE THE PATIENT, AND THE DETACHED SEGMENT WAS RETRIEVED WITHOUT COMPLICATION. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24304902 ↗
• MalfunctionNov 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DOCTOR EXPERIENCED A MALFUNCTION WITH THE INVOLVED NAVICROSS CATHETER, WHERE THE RADIO-OPAQUE MARKER SLIPPED OFF WHILE IN THE PATIENT. THE MARKER, WHICH RESEMBLES A RING, REMAINS IN THE PATIENT. THE TYPE OF PROCEDURE PERFORMED WAS AN IR PROCESS. THERE WAS NO REPORTED BLOOD LOSS. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 14 NOV 2024: THE SAMPLE IS CONTAMINATED BY BLOOD/BODY FLUID BUT IS NOT CONTAMINATED BY INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20701167 ↗
• InjuryNov 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DOCTOR EXPERIENCED A MALFUNCTION WITH THE INVOLVED NAVICROSS CATHETER, WHERE THE RADIO-OPAQUE MARKER SLIPPED OFF WHILE IN THE PATIENT. THE MARKER, WHICH RESEMBLES A RING, REMAINS IN THE PATIENT. THE TYPE OF PROCEDURE PERFORMED WAS AN IR PROCESS. THERE WAS NO REPORTED BLOOD LOSS. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 14 NOV 2024: THE SAMPLE IS CONTAMINATED BY BLOOD/BODY FLUID BUT IS NOT CONTAMINATED BY INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20701166 ↗
• InjuryMar 3, 2023Material Separation; Migration; Material Separation; Migration

  THE USER FACILITY REPORTED THAT ONE OF THE RADIOPAQUE MARKERS OF THE NAVICROSS CATHETER CAME OFF DURING THE PROCEDURE AND TRAVELED DOWN TO THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO TRAP IT WITH A STENT. FLUOROSCOPY VIDEO WAS AVAILABLE. THE MARKER WAS STENTED AGAINST THE VESSEL INTIMA. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION WAS RECEIVED ON 07 FEB 2023: THE PROCEDURE PERFORMED WAS A POPLITEAL ARTERY ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE PATIENT WAS SUCCESSFULLY TREATED, STABLE AND DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16479244 ↗
• InjuryMar 3, 2023Material Separation; Migration; Material Separation; Migration

  THE USER FACILITY REPORTED THAT ONE OF THE RADIOPAQUE MARKERS OF THE NAVICROSS CATHETER CAME OFF DURING THE PROCEDURE AND TRAVELED DOWN TO THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO TRAP IT WITH A STENT. FLUOROSCOPY VIDEO WAS AVAILABLE. THE MARKER WAS STENTED AGAINST THE VESSEL INTIMA. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION WAS RECEIVED ON 07 FEB 2023: THE PROCEDURE PERFORMED WAS A POPLITEAL ARTERY ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE PATIENT WAS SUCCESSFULLY TREATED, STABLE AND DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16479208 ↗
• InjuryJun 25, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  THE USER FACILITY REPORTED THAT DURING AN ATTEMPT TO STENT A RENAL ARTERY AFTER AN ENDOGRAFT MIGRATED UP AND COVERED THE ARTERY. THE NAVICROSS TIP BROKE OFF IN THE RENAL ARTERY. IT WAS STENTED OVER, AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. JUST THE TIP APPARENTLY BROKE OFF BECAUSE THEY COULD ONLY SEE ONE MARKER. A GLIDEWIRE WAS USED. RENAL ARTERY DID NOT HAVE CALCIFICATION. IT WAS DIFFICULT TO GET PAST THE AAA GRAFT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12066506 ↗
• InjuryJun 25, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ATTEMPT TO STENT A RENAL ARTERY AFTER AN ENDOGRAFT MIGRATED UP AND COVERED THE ARTERY. THE NAVICROSS TIP BROKE OFF IN THE RENAL ARTERY. IT WAS STENTED OVER, AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 15JUN2021. JUST THE TIP APPARENTLY BROKE OFF BECAUSE THEY COULD ONLY SEE ONE MARKER. A GLIDEWIRE WAS USED. RENAL ARTERY DID NOT HAVE CALCIFICATION. IT WAS DIFFICULT TO GET PAST THE AAA GRAFT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12066504 ↗
• InjurySep 11, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED WHILE USING A NAVICROSS 90 CM FOR A FISTULA CASE, WHEN THEY REMOVED THE CATHETER FROM THE PATIENT, IT WAS FOUND THAT THE RADIOPAQUE MARKER BANDS WERE MISSING. THEY BELIEVE THE MARKER BANDS REMAINED IN THE PATIENT, HOWEVER, THEY COULD NOT LOCATE THE MARKERS WITH IN THE PATIENT. THE PATIENT WAS STATED TO BE IN OK CONDITION. THE PROCEDURE OUTCOME WAS STATED TO BE OK. ADDITIONAL INFORMATION WAS RECEIVED ON 09-04-2018: THE MARKER BANDS WERE STILL IN THE PATIENT AND THEY ARE NOT GOING TO BE REMOVED. AN ULTRASOUND WAS USED TO LOCATE THE MISSING MARKER BANDS. THERE WAS NO METAL ENTRY NEEDLE USED WITH THE CATHETER. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL AND THERE WAS NO EXTENDED HOSPITAL STAY REQUIRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7863878 ↗