NITREX™ N351452Recalls & reported problems
Ev3, Inc · GW N351452 NITREX V04 · Class 2
All models of NITREX (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000185510), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A NITREX DEVICE WAS USED DURING A PROCEDURE TO TREAT A LESION OF MODERATE TORTUOSITY IN THE PROXIMAL POPLITEAL ARTERY. IT IS REPORTED THAT DURING THE PROCEDURE THERE WAS FRICTION WITH COATING WHEN GUIDEWIRE WAS GUIDED THROUGH PORT CATHETER AND THE COATING CAME LOOSE AND BLOCKED THE GUDIEWIRE. THERE WAS COMPONENT DAMAGE AND A SNARE RETRIEVAL DEVICE HAD TO BE USED TO RETRIEVE COMPONENT FORM THE PATIENT. THE PROCEDURE WAS COMPLETED BY ANOTHER 0.035 HYDROFIL GUIDEWIRE.
Patient problems: Insufficient Information
MAUDE report 17939249 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page