NITREX™ N143001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000185367), received between Nov 5, 2024 and Jul 24, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NITREX GUIDEWIRE DURING TREATMENT OF THE PATIENTS DISTAL ANTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, WHILE ATTEMPTING TO CROSS THE LESION, THE TIP OF THE GUIDEWIRE CAME LOOSE AND REMAINED IN THE CROSSING DEVICE. THE GUIDEWIRE WAS RECOVERED WHEN THE CROSSING DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587991 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE NITREX GUIDEWIRE, THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT'S RIGHT PERONEAL ARTERY, POTENTIALLY IN A COLLATERAL. A 6FR NON-MEDTRONIC SHEATH WAS USED. THE WIRE EXPERIENCED SEVERE RESISTANCE WHEN BEING ADVANCED BUT EXCESSIVE FORCE WAS NOT USED. THE TIP DETACHED AND REMAINED INSIDE THE VESSEL WITH NO INTERVENTION. THE ARTERY DIAMETER WAS NOTED TO BE BETWEEN 1.5-2MM, WITH MINIMAL TORTUOSITY AND MODERATE CALCIFICATION. THE PROCEDURE WAS COMPLETED USING A NEW NITREX GUIDEWIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941277 ↗
• MalfunctionFeb 21, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LEG ANGIOPLASTY PROCEDURE, THE OUTSIDE COATING SHREDDED OFF THE DISTAL END OF THE NITREX GUIDEWIRE WHEN THE PHYSICIAN ATTEMPTED TO PUT A NANOCROSS OVER THE WIRE. THE DEVICE WAS INSIDE THE PATIENT WHEN THE ISSUE OCCURRED. MODERATE RESISTANCE WAS NOTED DURING ADVANCEMENT. THE SHREDDED COATING COMPLETELY DETACHED OFF THE BACKEND OF THE WIRE OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SECOND WIRE WITH THE SAME NANOCROSS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21430575 ↗
• InjuryJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NITREX GUIDEWIRE DURING PATIENT TREATMENT. THE VESSEL WAS NOT PRE OR POST DILATED. WHEN THE NITREX GUIDEWIRE WAS REMOVED, A DISTAL END FRACTURE WAS NOTED AND THE TIP OF THE GUIDEWIRE HAD DETACHED IN THE PATIENTS VESSEL. A NON-MEDTRONIC SNARE/RETRIEVAL DEVICE WAS ADVANCED, HOWEVER IT WAS NOT POSSIBLE TO ADVANCE TO THE POSITION IN THE PERONEAL ARTERY DUE TO MULTIPLE SOLID PLAQUES IN THE POPLITEAL ARTERY AND THE ORIGIN OF THE PERONEAL ARTERY. MULTIPLE ANGIOPLASTIES WERE PERFORMED IN THE SEGMENTS MENTIONED WHERE THE PLAQUES WERE LOCATED. A NON-MEDTRONIC GUIDEWIRE AND A 6FR MULTIPURPOSE CATHETER WERE ADVANCED AND POSITIONED IN THE PERONEAL ARTERY. A NON-MEDTRONIC SNARE/RETRIEVAL DEVICE WAS ADVANCED AND THE NITREX DETACHED COMPONENT WAS CAPTURED. THE BALLOON WAS REMOVED, AND A CONTROL ANGIOGRAPHY WAS PERFORMED WITH ADEQUATE PATENCY OF THE SUPERFICIAL FEMORAL ARTERY, POPLITEAL, POSTERIOR TIBIAL, PERONEAL ARTERY AND TIBIOFIBULAR TRUNK. NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195454 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTED THAT DURING USE OF A NITREX GUIDEWIRE THE TIP DETACHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610128 ↗