GLIDEWIRE ADVANTAGE TRACK GAT1830Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350727848), received between Feb 26, 2021 and Sep 3, 2025 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathSep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A RIGHT LOWER LIMB ANGIOGRAPHY FOR SUPERFICIAL FEMORAL ARTERY CHRONIC TOTAL OCCLUSION, ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY USING A SIX FRENCH COOK ANSEL SHEATH. A 90-CENTIMETER QUICK-CROSS CATHETER AND A 260-CENTIMETER ANGLED GLIDEWIRE WERE USED TO CROSS THE CHRONIC TOTAL OCCLUSION, BUT THE ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY, ACCESS WAS OBTAINED VIA THE RIGHT ANTERIOR TIBIAL ARTERY USING AN 0.018-INCH, 300-CENTIMETER TRACK WIRE AND A 0.018-INCH, 135-CENTIMETER NAVICROSS CATHETER. THE NAVICROSS CATHETER WAS ADVANCED THROUGH THE ANTERIOR TIBIAL ARTERY, POPLITEAL ARTERY, AND INTO THE CHRONIC TOTAL OCCLUSION CAP. THE TRACK WIRE AND NAVICROSS CATHETER WERE ADVANCED INTO THE SIX FRENCH ANSEL SHEATH. THE WIRE WAS FLOSSED THROUGH THE SHEATH, WITH THE TRACK WIRE EXTENDING THROUGH THE SYSTEM. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE NAVICROSS CATHETER VIA THE PEDAL ACCESS. DURING REMOVAL, THE NAVICROSS CATHETER DID NOT ADVANCE OUT AS EXPECTED. ONE PHYSICIAN HELD THE WIRE AT THE GROIN SHEATH, WHILE A FELLOW MANAGED THE PEDAL WIRE, AND ANOTHER PHYSICIAN ATTEMPTED TO PULL THE NAVICROSS CATHETER. DURING THIS PROCESS, THE CATHETER SEPAR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 22957149 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A RIGHT LOWER LIMB ANGIOGRAPHY FOR SUPERFICIAL FEMORAL ARTERY CHRONIC TOTAL OCCLUSION, ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY USING A SIX FRENCH COOK ANSEL SHEATH. A 90-CENTIMETER QUICK-CROSS CATHETER AND A 260-CENTIMETER ANGLED GLIDEWIRE WERE USED TO CROSS THE CHRONIC TOTAL OCCLUSION, BUT THE ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY, ACCESS WAS OBTAINED VIA THE RIGHT ANTERIOR TIBIAL ARTERY USING AN 0.018-INCH, 300-CENTIMETER TRACK WIRE AND A 0.018-INCH, 135-CENTIMETER NAVICROSS CATHETER. THE NAVICROSS CATHETER WAS ADVANCED THROUGH THE ANTERIOR TIBIAL ARTERY, POPLITEAL ARTERY, AND INTO THE CHRONIC TOTAL OCCLUSION CAP. THE TRACK WIRE AND NAVICROSS CATHETER WERE ADVANCED INTO THE SIX FRENCH ANSEL SHEATH. THE WIRE WAS FLOSSED THROUGH THE SHEATH, WITH THE TRACK WIRE EXTENDING THROUGH THE SYSTEM. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE NAVICROSS CATHETER VIA THE PEDAL ACCESS. DURING REMOVAL, THE NAVICROSS CATHETER DID NOT ADVANCE OUT AS EXPECTED. ONE PHYSICIAN HELD THE WIRE AT THE GROIN SHEATH, WHILE A FELLOW MANAGED THE PEDAL WIRE, AND ANOTHER PHYSICIAN ATTEMPTED TO PULL THE NAVICROSS CATHETER. DURING THIS PROCESS, THE CATHETER SEPAR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 22953727 ↗
• MalfunctionJul 7, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A VASCULAR SURGERY PROCEDURE, A CROSSTELLA BALLOON FRACTURED (SEPARATED) FROM THE SHAFT AND HAD TO BE SURGICALLY REMOVED. IT WAS BEING USED IN CONJUNCTION WITH A GLIDEWIRE ADVANTAGE TRACK .018 WIRE. THE TYPE OF PROCEDURE PERFORMED WAS A PERIPHERAL ARTERY REVASCULARIZATION. THE REPORTED EVENT RESULTED IN PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 18JUN2025: THE PATIENT IS CURRENTLY IN THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22432653 ↗
• InjuryFeb 26, 2021Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED MW5101649. THE EVENT DESCRIPTION STATES: "WIRE BROKE OFF INSIDE PATIENT. WAS ABLE TO BE RETRIEVED."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385877 ↗
• InjuryFeb 26, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE RADIFOCUS WIRE BROKE OFF IN PATIENT. THE BROKEN WIRE WAS RETRIEVED FROM PATIENT AND THERE WAS NO HARM TO PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 22FEB2021. THE PROCEDURE BEING PERFORMED FOR THE PATIENT WHEN THE WIRE BREAKAGE OCCURRED WAS A RIGHT LOWER EXTREMITY DIAGNOSTIC ANGIOGRAM; BYPASS GRAFT SUPERFICIAL FEMORAL ARTERY TO POSTERIOR TIBIAL ARTERY. THEY WERE ABLE TO RETRIEVE THE WIRE DURING THE PROCEDURE. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385864 ↗