NITREX N351452Recalls & 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 00821684058275), received between May 26, 2020 and May 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
- Peeled/Delaminated1
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.
MalfunctionMay 26, 2020Peeled/Delaminated; Device Difficult to Setup or Prepare; Peeled/Delaminated; Device Difficult to Setup or Prepare
PHYSICIAN WAS ATTEMPTING TO USE A NITREX GUIDE WIRE ALONG WITH 7FR SHEATH DURING PROCEDURE TO TREAT A FIBROUS SOFT TISSUE LESION IN THE DIALYSIS ACCESS CIRCUIT. IFU WAS FOLLOWED. DAMAGED COMPONENT WAS NOTED DURING PREPARATION, THE END OF THE GUIDE WIRE WAS FRAYED AT THE BLUE (NON TIP) END. THE ISSUE WAS NOT NOTED PRIOR TO INTRODUCING THE DEVICE INTO THE PATIENT AND THE DEVICE ENTERED THE PATIENT'S VASCULATURE. IT WAS REPORTED THAT PHYSICIAN HAD TO UP SIZE SHEATH, PASS A BUDDY WIRE THROUGH LESION THEN REMOVE NITREX TO LOAD A PTA BALLOON ON NEW WIRE TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10086353 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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.
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