NITREX N143001Recalls & reported problems
Covidien LP · Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684058121), received between Mar 6, 2019 and Apr 9, 2020 — classified as 1 injury, 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
- Device Dislodged or Dislocated1
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2020Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
A NITREX GUIDE WIRE WAS BEING USED AND IT WAS REPORTED THAT PIECE OF THE GUIDE WIRE BROKE OFF THE DISTAL TIP AND WAS RETAINED WITHIN THE ARTERIAL VESSEL DURING ANGIO PROCEDURE OF THE LOWER EXTREMITY. PHYSICIAN DETERMINED THAT THERE WAS NO WAY TO REMOVE THE FRAGMENT AND IT WAS SAFE TO LEAVE WITHIN THE VESSEL. PATIENT WAS DISCHARGED HOME NEXT DAY AND WILL BE FOLLOWED UP FOR NORMAL POST SURGICAL MONITORING. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9942465 ↗MalfunctionMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NITREX NITINOL GUIDEWIRE TO TREAT A LESION IN THE MID POPLITEAL ARTERY WITH LITTLE TORTUOSITY AND MODERATE CALCIFICATION A PATIENT. THE VESSEL WAS NOT PREDILATED OR POST DILATED. IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THAT TIP DETACHED / TIP DAMAGE OCCURRED. GUIDEWIRE PROLAPSED DID NOT OCCUR CAUSING TIP DAMAGE OR EMBOLIZATION DURING THE PROCEDURE. THE PHYSICIAN WAS TRYING TO NAVIGATE AND CROSS THROUGH POP ARTERY. IT WAS NOTICED THAT THE WIRE LOOKED LIKE IT ¿J¿D¿ UNDER FLUORO AND THE PHYSICIAN SAID SOME WAS NOTED RESISTANCE SO PULLED WIRE. A SECTION OF WIRE THAT DETACHED WAS STUCK IN CXI SUPPORT CATHETER. THE CATHETER AND DETACHED WIRE WERE REMOVED WITH NO ISSUE. PHYSICIAN SELECTED NEW WIRE AND CONTINUED PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8393931 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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