NITREXRecalls & reported problems across all models

We found 11 models of NITREX by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2021 and Sep 2, 2026 — classified as 13 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NITREX problems

NITREX models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NITREX™ N180802

  Wire, guide, catheter
  8 reports
• NITREX™ N143001

  Wire, guide, catheter
  5 reports
• NITREX™ N183002

  Wire, guide, catheter
  5 reports
• NITREX™ N180601

  Wire, guide, catheter
  3 reports
• NITREX™ N180801

  Wire, guide, catheter
  3 reports
• NITREX™ N140801

  Wire, guide, catheter
  1 report
• NITREX™ N141802

  Wire, guide, catheter
  1 report
• NITREX™ N181805

  Wire, guide, catheter
  1 report
• NITREX™ N351452

  Wire, guide, catheter
  1 report
• NITREX™ N352601

  Wire, guide, catheter
  1 report
• NITREX™ N354001

  Wire, guide, catheter
  1 report

Recent NITREX adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 3, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE NITREX GUIDEWIRE IN THE DISTAL RIGHT INTERNAL JUGULAR VEIN TARGETING A FIBROUS LESION, WIRE DAMAGE OCCURRED, INCLUDING WIRE STRIPPING AND DETACHMENT OF THE RADIOPAQUE COATING FROM THE TIP OF THE WIRE WITHIN THE VESSEL. THE DETACHED RADIOPAQUE COATING COMPONENT WAS LEFT IN THE PATIENT WITH NO INTERVENTION, AND THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951853 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 7, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A LEFT FEMORAL-POPLITEAL BYPASS GRAFT WITH MINIMAL TORTUOSITY, THE PROXIMAL END OF THE NITREX GUIDEWIRE'S COATING PEELED BACK, PREVENTING THE BALLOON CATHETER FROM BEING PLACED ON THE WIRE. A 5FR 45CM NON-MEDTRONIC SHEATH WAS USED. AFTER THE WIRE WAS REMOVED FROM THE PATIENT, THE FLOPPY END OF THE WIRE DETACHED WHEN WIPED WITH A SALINE-SOAKED GAUZE PAD. THE DETACHMENT OCCURRED OUTSIDE OF THE BODY. THE VESSEL WAS PRE-DILATED USING A 5MMX40MM NON-MEDTRONIC DEVICE AND POST-DILATED USING A 6MMX40MM INPACT ADMIRAL DRUG COATED BALLOON. THE PROCEDURE WAS COMPLETED USING A NEW NON-MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089271 ↗
• 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 ↗
• 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 ↗

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