Traxcess SELECT GW1420040SRecalls & reported problems
Microvention, Inc. · Guidewires · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812636022260), received between Apr 22, 2017 and Jun 10, 2017 — classified as 1 death, 1 injury.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Perforation of Vessels2
- Death1
- Hemorrhage, Cerebral1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathJun 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF AN ANEURYSM, "THE DOCTOR PUNCHED AN ARTERY" AND A HEMORRHAGIC EVENT WAS OBSERVED A FEW SECONDS AFTER. IT WAS REPORTED THAT THE X-RAY DIDN'T WORK WHILE THE WIRE WAS ADVANCED. THE PATIENT WAS REPORTED TO HAVE DIED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 6632837 ↗InjuryApr 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING TREATMENT FOR SPASMOLYSIS IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), THE WIRE PERFORATED THE ICA, RESULTING IN INTERHEMISPHERICAL BLEEDING ABOVE THE CORPUS CALLOSUM. THE PATIENT WAS REPORTED TO BE ON ASS AND PLAVIX (DUAL ANTIPLATELET THERAPY) DUE TO RECENT IMPLANTATION OF A FLOW DIVERTER IN THE ICA. NO INTERVENTION WAS PERFORMED TO ADDRESS THE BLEEDING AT THE TIME OF THE PROCEDURE. THE PATIENT REMAINS VENTILATED AND CANNOT BREATHE ALONE; IT IS UNCLEAR HOW LONG THE PATIENT WILL NEED ASSISTED VENTILATION. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT HAS SUSTAINED ANY PERMANENT INJURY OR IMPAIRMENT.
Patient problems: Hemorrhage, Cerebral; Perforation of Vessels
MAUDE report 6514322 ↗
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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