NITREX™ N180601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000185374), received between Jun 11, 2024 and Sep 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that during placement of a line in the right internal jugular vein, challenging access required extensive guidewire manipulation and interventional radiology was requested to place the line. The lesion was fibrous. The patient had multiple upper extremity venous occlusions. Severe resistance was encountered during guidewire advancement, and excessive force was used.  A 035 angled non Medtronic (Glidewire) was advanced into the azygos vein and 5 French non Medtronic (Kumpe) catheter was advanced into the azygos vein. Central venous/azygous venography was performed confirming large caliber azygos venous collateral with brisk drainage into the IVC. Over a 027 guidewire, the 7 French non Medtronic (arrow) triple-lumen central venous catheter was advanced and positioned in the cephalad aspect of the azygos vein. Contrast injected confirming appropriate location and brisk flow .The procedure was completed before a retained Nitrex guidewire fragment was noticed. During the second advancement of the NITREX guidewire, the tip embolized into the vessel. Fluoroscopic imaging was used to localize the fragment. The overlying skin and deep soft tissue were anesthetized, a small i

  Patient problems: Insufficient Information

  MAUDE report 50560396 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NITREX GUIDEWIRE WAS USED IN AN INTERVENTIONAL RADIOLOGY CASE WHERE A WIRE FRAGMENT WAS LEFT BEHIND IN THE PATIENT RESULTING IN A RETAINED FOREIGN OBJECT. THERE WERE MULTIPLE NON-MEDTRONIC GUIDEWIRES ALSO USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE LEFT THE FRAGMENT. THE WIRE FRAGMENT WAS NOT REMOVED BECAUSE IT WAS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424304 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTS THAT DURING A BILIARY DRAIN PROCEDURE UNDER MODERATE SEDATION, WHILE FEEDING NITREX WIRE THROUGH BEVELED NEEDLE, A SMALL TIP OF NITREX WIRE BROKE IN TRACK. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508679 ↗