NITREX™ N180802Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000185404), received between Mar 26, 2021 and Aug 25, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Detachment of Device or Device Component

  It was reported that during thrombectomy for a left distal external iliac vein femoral deep vein thrombosis, the NITREX guidewire was inserted through a 4 Fr micropuncture introducer sheath and repositioned several times while attempting to access a vein containing thrombus. The distal end of the wire separated from the wire body within the vessel. The detached distal wire component was retrieved using a snare. The procedure was continued with a new device. The event was associated with an approximately 20-minute surgical delay. No patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50429478 ↗
• InjuryMar 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT PROCEDURE, APPROXIMATELY 2-3 CM OF A NITREX GUIDEWIRE WAS SHEARED OFF DURING THE PROCEDURE AND LEFT IN THE PATIENT'S RIGHT FLANK SUBCUTANEOUS TISSUE. AN ATTEMPT WAS MADE TO RETRIEVE WITH FORCEPS, HOWEVER THIS WAS UNSUCCESSFUL AND THE FRAGMENT WAS LEFT IN THE PATIENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Embolism/Embolus

  MAUDE report 24581007 ↗
• InjuryApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE N180802 NITREX GUIDEWIRE, WIRE DAMAGE WAS REPORTED. THE TIP FRACTURED AND DETACHED WITHIN THE PATIENTS VESSEL. INTERVENTION WAS REQUIRED AND THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853848 ↗
• InjuryOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NITREX GUIDEWIRE DURING TREATMENT OF THE PATIENTS RIGHT PROXIMAL RENAL VEIN. MODERATE VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE TIP OF GUIDEWIRE BROKE OFF IN THE PATIENTS VESSEL. PHYSICIAN USED A SNARE TO REMOVE DETACHED COMPONENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344082 ↗
• MalfunctionJun 24, 2022Defective Device; Defective Device

  PHYSICIAN WAS ATTEMPTING TO USE A NITREX GUIDEWIRE DURING PROCEDURE. IFU WAS FOLLOWED. TIP DETACHED/TIP DAMAGED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800567 ↗
• MalfunctionAug 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NITREX WIRE DURING A PROCEDURE OF A VASCULAR ACCESS ATTEMPT ON A CHRONIC KIDNEY DIALYSIS PATIENT POST KIDNEY TRANSPLANT. NUMEROUS FAILED GRAFTS AS WELL AS POST SURGICAL SCARRING OF BILATERAL LEGS AND INGUINAL AREA. IT IS REPORTED A SMALL FRAGMENT OF THE NITREX WIRE REMAINED WITHIN THE PATIENT DURING INITIAL ATTEMPT AT ACCESS DUE TO EXTENSIVE SCAR TISSUE/ADHESIONS. THE FRAGMENT IS RETAINED IN THE SUBCUTANEOUS TISSUES OF THE LEFT THIGH AND IS LIKELY OF LITTLE CLINICAL SIGNIFICANCE. IT IS REPORTED MULTIPLE OTHER VESSELS WERE IMAGED VIA ULTRASOUND AND FOUND TO BE OCCLUSIVE MAKING THE LEFT COMMON FEMORAL ARTERY THE ONLY ACCESSIBLE VESSEL DESPITE THE EXTENSIVE OVERLYING SCAR TISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12306386 ↗
• InjuryMay 11, 2021Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  PHYSICIAN USED A NITREX GUIDEWIRE WITH AN 8FR NON-MEDTRONIC SHEATH DURING A PROCEDURE TO TREAT A LESION IN THE PATIENT¿S MID LEFT CEPHALLIC ARCH. LESION EXHIBITED 90% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE WIRE GOT STUCK IN THE LESION WHEN TRYING TO CROSS A LESION IN THE LEFT CEPHALLIC ARCH. THE DISTAL TIP OF THE WIRE UNRAVELED AND THE VERY TIP BROKE OFF AND WAS LEFT IN THE PATIENT. IT WAS STENTED OVER WITH A NON-MEDTRONIC COVERED STENT. THE NITREX WAS USED IN CONJUNCTION WITH AN .035" NON-MEDTRONIC CROSSING CATHETER. THE APPROACH WAS FROM THE LEFT ARM AND THE LEFT BRACHIOCEPHALIC VEIN. PATIENT IS STABLE AND IN GOOD CONDITION. NO INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11804918 ↗
• MalfunctionMar 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED 0.018" NITREX GUIDEWIRE ALONG WITH 5FR MICRO PUNCTURE SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID PEDAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2MM AND 150MM-200MM RESPECTIVELY. THE TIP DETACHED IN THE VESSEL. IT WAS REPORTED THAT THE TIP OF THE WIRE REMAINS IN THE PATIENT. PHYSICIAN BELIEVES THE TIP OF THE WIRE IS IN THE SOFT TISSUE NOT THE ARTERY. PHYSICIAN ACCESSED DORSALIS ARTERY UNDER THE GUIDANCE OF ULTRASOUND. THE MICRO PUNCTURE NEEDLE ACCESSED THE ARTERY, ONCE PHYSICIAN SAW BLOOD COMING THROUGH THE NEEDLE, NITREX 0.018" GUIDEWIRE WAS INSERTED. SINCE ACCESS WAS ABOUT 3-4CM BELOW CTO, THE WIRE DID NOT GO FAR DEEP INTO VESSEL. PHYSICIAN THEN REMOVED THE NEEDLE AND PUT MICRO PUNCTURE SHEATH AND THEN REMOVED THE WIRE. ONCE THE PHYSICIAN INJECTED CONTRAST, IT WAS VISIBLE THAT THE MICRO PUNCTURE SHEATH WAS OUTSIDE THE VESSEL AND THE BLACK TIP OF THE WIRE WAS VISIBLE ANGIOGRAPHICALLY AS WELL. THE MICRO PUNCTURE SHEATH WAS REMOVED. PHYSICIAN HAD CONTRALATERAL ACCESS FROM COMMON FEMORAL ARTERY. GUIDE CATHETER WAS ADVANCED INTO POPLITEAL A RTERY, IMAGES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575371 ↗