NITREX™ N183002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000185459), received between Aug 3, 2023 and Feb 4, 2026 — classified as 3 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY, WIRE DAMAGE/FRAYING WAS OBSERVED WITH THE NITREX GUIDEWIRE. A 7X45 NON-MEDTRONIC SHEATH AND AN EMBOLIC PROTECTION DEVICE WERE USED. THE VESSEL WAS POST-DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. NOTHING DETACHED OFF THE NITREX GUIDEWIRE AND NO INTERVENTION WAS REQUIRED FOR REMOVAL OF THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW PRODUCT WAS NOT REQUIRED AS THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257899 ↗
• InjurySep 9, 2025Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A SEVERE CALCIFIED LESION WITH 97% STENOSIS AND 200 MM LENGTH IN THE PROXIMAL RIGHT ANTERIOR TIBIAL ARTERY, USING THE NITREX GUIDEWIRE, WIRE DAMAGE OCCURRED, INCLUDING WIRE STRIPPING AND TIP DETACHMENT AT THE TARGET LESION. THE TIP WAS SNARED AND REMOVED. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT NO EXCESSIVE FORCE WAS USED. A 6FR NON-MEDTRONIC SHEATH WAS USED AND THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE VESSEL WAS POST-DILATED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002737 ↗
• InjuryOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A NITREX GUIDEWIRE TO TREAT A CALCIFIED LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS 90%. LESION LENGTH WAS 80MM. ARTERY/VEIN DIAMETER WAS 5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A 7X45 TERUMO DESTINATION SHEATH WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A MEDTRONIC PACIFIC PLUS BALLOON. THE VESSEL WAS POST-DILATED WITH A MEDTRONIC NANOCROSS BALLOON. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IFU WAS FOLLOWED WITHOUT ISSUE. WIRE DAMAGE OCCURRED. WHILE ATTEMPTING TO CROSS THE LESION, THE TIP OF THE NITREX WIRE DETACHED IN THE PATIENT¿S LEFT PROFUNDA ARTERY. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE DETACHED TIP WITH A GOOSE NECK SNARE. PART OF THE DETACHED TIP CAME OUT, BUT A PORTION OF THE TIP STILL REMAINED. PHYSICIAN WAS UNABLE TO PERFORM ATHERECTOMY TO THE LESION BECAUSE OF THE DETACHED TIP. THE PHYSICIAN DECIDED TO LEAVE THE TIP OF THE WIRE INSIDE THE PATIENT AND BRING THEM TO THE HOSPITAL IN TWO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471089 ↗
• MalfunctionOct 15, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A NITREX GUIDEWIRE WITH A 7X45 NON-MEDTRONIC (TERUMO DESTINATION) SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. 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. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE NITREX WIRE WAS REMOVED FROM THE PATIENT TO EXCHANGE FOR A DIFFERENT WIRE TO HELP CROSS THE LESION. WHEN THE PHYSICIAN EXAMINED THE TIP OF THE WIRE, HE NOTICED THAT THE WIRE HAD SPLIT AT THE TIP, THERE WAS NO COMPONENT DETACHMENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450585 ↗
• InjuryAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS IMPLANTING A NON-MEDTRONIC PRESSURE MONITORING SYSTEM. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE SHEARED OFF INTO THE PULMONARY ARTERY. THE TIP OF THE WIRE WAS RETRIEVED. THERE WAS NO DEVIATION FROM PRACTICE. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450610 ↗