NITREX N183002Recalls & reported problems
Covidien LP · Guidewire · 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 00821684058213), received between Dec 6, 2018 and Dec 6, 2018 — 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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionDec 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN USED A NITREX GUIDEWIRE WITH A TRAILBLAZER DEVICE DURING TREATMENT OF A 230MM PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. IT IS REPORTED THAT THE TIP OF THE NITREX DEVICE WAS PROLAPSED OUTSIDE .035 X 135 TRAILBLAZER IN ATTEMPT TO CROSS SFA CTO. WHEN WITHDRAWING THE WIRE FROM THE TRAILBLAZER, THE NITREX WIRE BROKE. THE PHYSICIAN THEN REMOVED THE TRAILBLAZER WITH THE REMAINING WIRE (WITH TIP). NO PART OF THE WIRE REMAINED IN THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING A .035 X 260 (GLIDEWIRE ADVANTAGE) NON-MEDTRONIC WIRE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8137213 ↗
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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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