NAVICROSS NC18150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987892077296), received between Oct 29, 2024 and Oct 29, 2024 — 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.

• InjuryOct 29, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A 018 STRAIGHT NAVICROSS CATHETER WAS ADVANCED IN THE TP TRUNK OVER THE .014 GLIDEWIRE ADVANTAGE. THE PHYSICIAN THEN TRIED TO PASS THE NAVICROSS THROUGH A TIGHT LESION INTO THE PATIENT. HE HAD TROUBLE PUSHING IT OVER THE WIRE. THE PHYSICIAN THEN SAID IT FELT AS IF THE CATHETER POPPED THROUGH. ONCE HE RETRACTED THE NAVICROSS CATHETER BACK INTO THE TP TRUNK, WE SAW REMANENCE OF WHAT APPEARED TO BE THE HYDROPHILIC COATING SLUFF OFF IN THE PATIENT VESSEL. THE PHYSICIAN REMOVED ALL EQUIPMENT FROM THE PATIENT'S VESSEL AND THERE WERE TWO PIECES OF FOREIGN BODY LEFT BEHIND. WE HAD TO SNARE THE TWO PIECES OF BLACK REMANENCE OUT. THE PROCEDURE WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 11OCT2024: THE SAMPLE WAS IN THE BODY AND REMOVED. THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED AFTER THE REMOVAL OF THE FOREIGN BODY. THE ADDITIONAL DEVICES USED WERE A .014 GLIDEWIRE ADVANTAGE AND SNARE TO REMOVE THE FOREIGN BODY. THE PATIENT WAS INTUBATED AND UNDER A DRAPE, MAKING IT HARD TO VISUALIZE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20558194 ↗
• InjuryOct 29, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A 018 STRAIGHT NAVICROSS CATHETER WAS ADVANCED IN THE TP TRUNK OVER THE .014 GLIDEWIRE ADVANTAGE. THE PHYSICIAN THEN TRIED TO PASS THE NAVICROSS THROUGH A TIGHT LESION INTO THE PATIENT. HE HAD TROUBLE PUSHING IT OVER THE WIRE. THE PHYSICIAN THEN SAID IT FELT AS IF THE CATHETER POPPED THROUGH. ONCE HE RETRACTED THE NAVICROSS CATHETER BACK INTO THE TP TRUNK, WE SAW REMANENCE OF WHAT APPEARED TO BE THE HYDROPHILIC COATING SLUFF OFF IN THE PATIENT VESSEL. THE PHYSICIAN REMOVED ALL EQUIPMENT FROM THE PATIENT'S VESSEL AND THERE WERE TWO PIECES OF FOREIGN BODY LEFT BEHIND. WE HAD TO SNARE THE TWO PIECES OF BLACK REMANENCE OUT. THE PROCEDURE WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 11OCT2024: THE SAMPLE WAS IN THE BODY AND REMOVED. THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED AFTER THE REMOVAL OF THE FOREIGN BODY. THE ADDITIONAL DEVICES USED WERE A .014 GLIDEWIRE ADVANTAGE AND SNARE TO REMOVE THE FOREIGN BODY. THE PATIENT WAS INTUBATED AND UNDER A DRAPE, MAKING IT HARD TO VISUALIZE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20558121 ↗