NITREX™ N352601 (UDI 00821684058343)Recalls & reported problems
Covidien LP · GW N352601 NITREX V03 · Class 2
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 00821684058343), received between Jun 14, 2017 and Jun 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delamination” (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.
Most reported problems
Device problems
- Delamination1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2017Delamination; Delamination
THE PHYSICIAN INTENDED TO USE THE SPIDER FX AND NITREX GUIDEWIRE AS PER IFU. IT WAS REPORTED THE TRAILBLAZER CATHETER WAS LOADED ONTO NITREX WIRE AND MET RESISTANCE AND WAS UNABLE TO PASS FURTHER. THE SPIDER WAS LOADED INTO DELIVERY CATHETER; RESISTANCE WAS ENCOUNTERED RESULTING IN A KINK IN THE SPIDER. BOTH DEVICES WERE REPLACED AND USED WITH THE TRAILBLAZER CATHETER FOR THE PROCEDURE. NO INJURY TO THE PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6640999 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
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- 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.
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