NITREX N141802Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684058114), received between Mar 20, 2019 and Mar 20, 2019 — 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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN WAS INTENDING TO USE A NITREX GUIDEWIRE TO TREAT A 210MM SEVERELY CALCIFIED CTO IN THE RIGHT DISTAL TIBIAL/POPLITEAL TRUNK AND POSTERIOR TIBIAL ARTERY. MODERATE TORTUOSITY WAS REPORTED AND THE ARTERY DIAMETER WAS 3MM. A NON MEDTRONIC 7FR 23CM SHEATH AND A 0.014 X 180CM GUIDEWIRE WERE USED IN THE PROCEDURE. THE VESSEL WAS PREDILATED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED FROM THE WIRE AT THE TARGET LESION WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE FROM THE ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED PART USING A 7FR 120CM SNARE BUT COULD NOT REMOVE IT FROM THE PATIENT. THE TIP REMAINS INSIDE THE PATIENT AT THE DISTAL POSTERIOR TIBIAL ARTERY.
Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem
MAUDE report 8435610 ↗
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- 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.
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