ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor 9515Recalls & reported problems
Volcano Corporation · 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 00184360000334), received between Dec 6, 2018 and Dec 6, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, AFTER INTRODUCTION OF THE MANUFACTURER'S DEVICE, IN A VERY TORTUOUS VESSEL, IMMEDIATE DISSECTION OF THE CX CORONARY ARTERY AND SUBSEQUENT OCCLUSION OF THE CX OCCURRED. IT WAS DECIDED TO IMMEDIATELY STENT THIS ARTERY, NO MEASUREMENTS WERE PERFORMED. THIS WAS POSSIBLY DUE TO THE COMBOWIRE. THE PATIENT RECOVERED WELL AND HAS NO COMPLAINTS. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE PATIENT'S VESSEL WAS DISSECTED WHILE THE MANUFACTURER'S DEVICE WAS IN USE AND ADDITIONAL INTERVENTION WAS PERFORMED.
Patient problems: Vascular Dissection
MAUDE report 8140605 ↗
Other Wire, Guide, Catheter devices
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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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