GLIDEWIRE ADVANTAGE TRACK GAT1818Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE ADVANTAGE TRACK Guide wire · Class 2
Data updated Oct 18, 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 04987350727824), received between Jan 10, 2024 and Jan 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED INTERVENTIONAL RADIOLOGY WAS PERFORMED, NEPHROSTOMY TUBE EXCHANGE PROCEDURE AND USED A CHIBA NEEDLE. THE TIP OF THE GWAT WAS COMING OFF FROM THE MAIN BODY OF THE WIRE. IT ADVANCED FINE, HOWEVER WHEN THEY TRIED TO BRING IT BACK THROUGH, RESISTANCE WAS ENCOUNTERED. CUSTOMER ACKNOWLEDGED THAT THE PURPOSE OF USE IS NOT ADVISED. THE PATIENT IS FINE AND HAD NO ISSUES. CUSTOMER OPENED A NEW PRODUCT AND WAS USED SUCCESSFULLY. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 15 DEC 2023: THERE WERE NO FRAGMENTS LEFT IN THE PATIENT'S BODY. THE WIRE DID NOT APPEAR TO BE DAMAGED PRIOR TO USE. THE SAMPLE IS NOT CONTAMINATED BY INFECTIOUS OR ANTI-CANCER AGENTS. THE SAMPLE DOES NOT HAVE VISIBLE BLOOD, BUT IT IS IN A BIOHAZARD BAG AND WAS IN THE PATIENT'S BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490350 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page