GLIDEWIRE ADVANTAGE GA1818Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04987350714749), received between Aug 9, 2018 and Aug 27, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE PATIENT HAD A HISTORY OF PERIPHERAL ARTERY DISEASE AND WAS BEING TREATED IN THE CATH LAB FOR SEVERE CLAUDICATION. AFTER PERFORMING INITIAL ANGIOGRAM, IT SHOWED THE PATIENT HAD A CHRONIC TOTAL OCCLUSION OF THE RIGHT POPLITEAL ARTERY. THE PHYSICIAN ATTEMPTED TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) WITH THE WIRE THROUGH A .018 COOK CXI CROSSING CATHETER. THE CATHETER AND WIRE WERE ADVANCED THROUGH SUB INTIMAL SPACE. THE WIRE WAS MANIPULATED TO REENTER INTO TRUE LUMEN, AND THEY NOTICED THE TIP HAD BROKEN OFF. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO RETRIEVE THE TIP OF THE WIRE WITH A SNARE; HOWEVER, IT WAS UNSUCCESSFUL. AFTER MULTIPLE ATTEMPTS TO RECANALIZE THE ARTERY THE PHYSICIAN WAS UNSUCCESSFUL, AND THE CASE WAS ABORTED. THERE WAS NO NEGATIVE OUTCOME FOR THE PATIENT POST PROCEDURE. THE PROCEDURE PERFORMED WAS A RIGHT LOWER EXTREMITY ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 13AUG2025: THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 22904834 ↗
• InjuryAug 27, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE PATIENT HAD A HISTORY OF PERIPHERAL ARTERY DISEASE AND WAS BEING TREATED IN THE CATH LAB FOR SEVERE CLAUDICATION. AFTER PERFORMING INITIAL ANGIOGRAM, IT SHOWED THE PATIENT HAD A CHRONIC TOTAL OCCLUSION OF THE RIGHT POPLITEAL ARTERY. THE PHYSICIAN ATTEMPTED TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) WITH THE WIRE THROUGH A .018 COOK CXI CROSSING CATHETER. THE CATHETER AND WIRE WERE ADVANCED THROUGH SUB INTIMAL SPACE. THE WIRE WAS MANIPULATED TO REENTER INTO TRUE LUMEN, AND THEY NOTICED THE TIP HAD BROKEN OFF. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO RETRIEVE THE TIP OF THE WIRE WITH A SNARE; HOWEVER, IT WAS UNSUCCESSFUL. AFTER MULTIPLE ATTEMPTS TO RECANALIZE THE ARTERY THE PHYSICIAN WAS UNSUCCESSFUL, AND THE CASE WAS ABORTED. THERE WAS NO NEGATIVE OUTCOME FOR THE PATIENT POST PROCEDURE. THE PROCEDURE PERFORMED WAS A RIGHT LOWER EXTREMITY ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 13AUG2025: THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 22904833 ↗
• MalfunctionOct 28, 2022Material Separation; Positioning Problem; Material Separation; Positioning Problem

  THE USER FACILITY REPORTED THAT THE DOCTOR USED THE .018 180CM GLIDEWIRE ADVANTAGE DEVICE WHILE WORKING ON AN ILIAC LESION. THE WIRE WAS PUT UP AND TAKEN OUT, EVERYTHING WAS FINE. THE WIRE WAS PUT BACK IN AND IT FELT STIFF; THEREFORE, THE WIRE WAS PULLED OUT AND THE TIP WAS GONE. THE DOCTOR STATED HE WAS NOT BEING ROUGH WITH THE WIRE AND HAD BEEN MORE AGGRESSIVE WITH THAT WIRE IN THE PAST. ACCESS WAS RIGHT FEMORAL THROUGH A CORDIS SHEATH. THE OUTCOME OF THE PROCEDURE WAS GOOD. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 12 OCT 2022: THE DOCTOR REPORTED THAT THE TIP CAME OFF. THEY RETRIEVED THE TIP OF THE WIRE FROM THE CATHETER. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 13 OCT 2022: NO INTERVENTION WAS NECESSARY. THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 14 OCT 2022: IT WAS UNKNOWN IF THE PATIENT HAD ANY UNDERLYING INFECTIONS AND OR ANTI-CANCER AGENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693312 ↗
• MalfunctionDec 8, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD AN ISSUE WHILE USING THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE, GA1818 DURING A PERCUTANEOUS NEPHROSTOMY. WHEN DELIVERING THE WIRE THROUGH THE ACCUSTICK SYSTEM (BOSTON SCIENTIFIC) THE GLIDEWIRE PORTION ROLLED UP AND PREVENTED THE WIRE FROM BEING USED THROUGH THE SYSTEM. THE ACCUSTICK DOES CONTAIN A STIFF (METAL) INNER CANNULA AND THIS WAS INSERTED INTO THE RENAL PELVIS THAT CONTAINED STONES. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. THE WIRE AND ACCUSTICK WERE REMOVED. ACCESS WAS REGAINED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964972 ↗
• MalfunctionMar 20, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE RADIFOCUS WIRE BROKE APART. THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 13, 2019. THE WIRE WAS SHREDDED; HOWEVER, THE COMPONENTS WERE REMOVED FROM THE PATIENT. BLOOD LOSS WAS LESS THAN 250 CC.

  Patient problems: Blood Loss

  MAUDE report 8435914 ↗
• MalfunctionAug 9, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE WIRE BROKE OFF BUT WAS RETRIEVED AND REMOVED INSIDE OF THE CATHETER. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 8/7/2018: THE PROCEDURE BEING PERFORMED WAS A PERCUTANEOUS NEPHROLITHOTOMY (PCN) AND URETERAL STENT PLACEMENT. PART OF THE BROKEN WIRE WAS IN THE CATHETER, SO THE PHYSICIAN MANEUVERED THE CATHETER UNTIL HE COULD SEE THE BROKEN PART OF THE WIRE. THE PHYSICIAN THEN USED A HEMOSTAT IN THE HUB AND PULLED OUT THE BROKEN PIECE. ALL OF THE WIRE WAS ABLE TO BE REMOVED FROM THE PATIENT. A 4FR TERUMO ANGLED GLIDE CATHETER AND A 6FR ACCUSTICK WERE USED WITH THE INVOLVED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768250 ↗