NITREX™ N180801Recalls & reported problems
Ev3, Inc · GW N180801 NITREX V04 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000185398), received between Apr 26, 2021 and Sep 3, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A NITREX GUIDEWIRE WAS BEING USED DURING LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDIATRIC CARDIAC CATHETERIZATION. IT WAS USED IN CONJUNCTION WITH A 21G ARTERIAL NEEDLE. THE TIP OF THE NITREX GUIDEWIRE SHEARED OFF AND WAS RETAINED EXTRAVASCULARLY. SURGEON AND PEDIATRIC SURGERY DOCTOR WERE CONTACTED AND IT WAS DETERMINED IT WAS SAFE TO LEAVE IN PLACE. PROCEEDED AND COMPLETED CASE WITH NO OTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17376908 ↗InjuryApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT IR PHYSICIAN WAS USING A NITREX 80CM GUIDEWIRE FOR A NEPHROSTOMY CASE. DURING PROCEDURE, PHYSICIAN WENT TO PULL THE WIRE OUT AND IT SHEARED OFF INSIDE THE PATIENT. THE PHYSICIAN USED A SNARE AND RETRIEVED THE FRACTURED WIRE. NO FURTHER INJURY REPORTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 11722635 ↗
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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