NITREX™ N352601 (UDI 00763000185589)Recalls & reported problems
Ev3, Inc · GW N352601 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000185589), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.
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
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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