NAVICROSS NC18131Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04987892077272), received between Mar 18, 2021 and Aug 10, 2025 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathAug 10, 2025Break; Difficult to Remove; Break; Difficult to Remove

  THE USER FACILITY REPORTED THAT DURING A RIGHT LOWER LIMB ANGIOGRAPHY FOR SUPERFICIAL FEMORAL ARTERY CHRONIC TOTAL OCCLUSION, ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY USING A SIX FRENCH COOK ANSEL SHEATH. A 90-CENTIMETER QUICK-CROSS CATHETER AND A 260-CENTIMETER ANGLED GLIDEWIRE WERE USED TO CROSS THE CHRONIC TOTAL OCCLUSION, BUT THE ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY, ACCESS WAS OBTAINED VIA THE RIGHT ANTERIOR TIBIAL ARTERY USING AN 0.018-INCH, 300-CENTIMETER TRACK WIRE AND A 0.018-INCH, 135-CENTIMETER NAVICROSS CATHETER. THE NAVICROSS CATHETER WAS ADVANCED THROUGH THE ANTERIOR TIBIAL ARTERY, POPLITEAL ARTERY, AND INTO THE CHRONIC TOTAL OCCLUSION CAP. THE TRACK WIRE AND NAVICROSS CATHETER WERE ADVANCED INTO THE SIX FRENCH ANSEL SHEATH. THE WIRE WAS FLOSSED THROUGH THE SHEATH, WITH THE TRACK WIRE EXTENDING THROUGH THE SYSTEM. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE NAVICROSS CATHETER VIA THE PEDAL ACCESS. DURING REMOVAL, THE NAVICROSS CATHETER DID NOT ADVANCE OUT AS EXPECTED. ONE PHYSICIAN HELD THE WIRE AT THE GROIN SHEATH, WHILE A FELLOW MANAGED THE PEDAL WIRE, AND ANOTHER PHYSICIAN ATTEMPTED TO PULL THE NAVICROSS CATHETER. DURING THIS PROCESS, THE CATHETER SEPAR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 22768337 ↗
• InjuryAug 10, 2025Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED ON 04 AUG 2025: UPON INSPECTION OF THE ACTUAL SAMPLE, IT WAS OBSERVED THAT THE 018300CM TRACK MAY ALSO BE A CONTRIBUTING FACTOR. ADDITIONAL INFORMATION WAS RECEIVED ON 07 AUG 2025: THE PRODUCT IN QUESTION WAS IDENTIFIED AS THE GAT1830 GUIDEWIRE ADVANTAGE TRACK 018 300CM. IT WAS CONFIRMED THAT THE WIRE IS NOT CONTAMINATED WITH ANY ANTICANCER DRUG. ADDITIONALLY, THE ASSISTING PROVIDER INDICATED THAT THEY DID NOT BELIEVE THE PRODUCT WAS THE CAUSE OF THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 22768319 ↗
• InjurySep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5119966. THE EVENT DESCRIPTION STATED THAT INVOLVED DEVICE CATHETER TIP WAS IMPACTED AND DETACHED FROM THE CATHETER WHEN THE PROVIDER ENCOUNTERED SIGNIFICANT AMOUNT OF CALCIFIC DISEASE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17742149 ↗
• InjurySep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5119966. THE EVENT DESCRIPTION STATED THAT INVOLVED DEVICE CATHETER TIP WAS IMPACTED AND DETACHED FROM THE CATHETER WHEN THE PROVIDER ENCOUNTERED SIGNIFICANT AMOUNT OF CALCIFIC DISEASE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17742128 ↗
• InjuryMar 18, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY, A FOREIGN BODY APPEARED AT THE TIP OF THE NAVICROSS CATHETER. IT APPEARED TO COME FROM EITHER THE NAVICROSS 18 OR THE V14 WIRE THAT WAS ALSO USED FOR THE PROCEDURE. THE FOREIGN BODY WAS STENTED TO THE WALL OF THE VESSEL WITHOUT INCIDENT AND THE PATIENT HAD A SUCCESSFUL PROCEDURE. UPON INITIAL EXAMINATION WITH THE NAKED EYE, IT WAS DIFFICULT TO TELL IF THERE WAS ANY MISSING COMPONENT TO THE TIP OF THE NAVICROSS 18. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11518532 ↗
• InjuryMar 18, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY, A FOREIGN BODY APPEARED AT THE TIP OF THE NAVICROSS CATHETER. IT APPEARED TO COME FROM EITHER THE NAVICROSS 18 OR THE V14 WIRE THAT WAS ALSO USED FOR THE PROCEDURE. THE FOREIGN BODY WAS STENTED TO THE WALL OF THE VESSEL WITHOUT INCIDENT AND THE PATIENT HAD A SUCCESSFUL PROCEDURE. UPON INITIAL EXAMINATION WITH THE NAKED EYE, IT WAS DIFFICULT TO TELL IF THERE WAS ANY MISSING COMPONENT TO THE TIP OF THE NAVICROSS 18. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11518525 ↗