Nit-Vu 05800124Recalls & reported problems
Angiodynamics, Inc. · High Perfomanace Micro Guidewire, NITINOL, STRAIGHT, 2 CM COIL, STIFF · 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 H787058001240), received between Apr 13, 2017 and Apr 13, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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
- Crack1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2017Crack; Crack
AS REPORTED TO (B)(4) ON JUNE 12, 2014: DURING AN ABSCESS DRAIN PROCEDURE OF THE GLUTEAL MUSCLE, UNDER CT GUIDANCE, A NIT-VU GUIDEWIRE FRACTURED INSIDE OF THE PATIENT. DURING THE PROCEDURE, THE CATHETER WAS ADVANCED OVER THE WIRE. THE PHYSICIAN FELT TENSION WHEN PULLING WIRE BACK. IT WAS NOTED THE GUIDEWIRE HAD FRACTURED WHEN THE DOCTOR PULLED IT BACK FROM THE CATHETER OUT OF THE PATIENT. THE FRACTURED PIECE WAS NOT RETRIEVED. IT WAS REPORTED THE PATIENT SUFFERED NO SERIOUS HARM OR INJURY DUE TO THE EVENT . THE REPORTED DEFECTIVE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6489381 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- 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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