GLIDEWIRE ADVANTAGE GA3501Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04987350703620), received between Apr 9, 2019 and Mar 16, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 18, 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.

• InjuryMar 16, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER THE PROCEDURE WHEN THE GLIDEWIRE WAS REMOVED, THE END OF THE WIRE APPEARED TO HAVE SHREDDED, AND PART OF THE TIP/PLASTIC REMAINED INSIDE THE PATIENTS GROIN AREA. THEY WERE ABLE TO REMOVE THE PIECE FROM THE PATIENT. ESTABLISHMENT VASCULAR ACCESS FEMORAL APPROACH FOR ENDOVASCULAR STENT INSERTION INTO ABDOMINAL AORTIC ANEURYSM WAS THE PROCEDURE PERFORMED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24606328 ↗
• InjuryMay 7, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDEWIRE ADVANTAGE WAS USED THROUGH A METAL CYSTOSCOPE DURING A CYSTOSCOPE PROCEDURE. DURING WITHDRAWAL IT WAS NOTICED THAT SOME OF GREEN/WHITE PORTION OF WIRE WAS SHAVED OFF. 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. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17APR2024: THE GREEN/WHITE PORTION OF THE WIRE DID SHAVE OFF INSIDE THE PATIENT. THE SHAVED PORTION WAS REMOVED THROUGH METAL CYSTOSCOPE. IT WAS UNKNOWN IF THE PATIENT HAD PLAQUE OR STENOSIS PRESENT. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19259115 ↗
• InjuryMay 7, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDEWIRE ADVANTAGE WAS USED THROUGH A METAL CYSTOSCOPE DURING A CYSTOSCOPE PROCEDURE. DURING WITHDRAWAL IT WAS NOTICED THAT SOME OF GREEN/WHITE PORTION OF WIRE WAS SHAVED OFF. 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. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17APR2024: THE GREEN/WHITE PORTION OF THE WIRE DID SHAVE OFF INSIDE THE PATIENT. THE SHAVED PORTION WAS REMOVED THROUGH METAL CYSTOSCOPE. IT WAS UNKNOWN IF THE PATIENT HAD PLAQUE OR STENOSIS PRESENT. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19258884 ↗
• MalfunctionFeb 7, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE COATING OF THE ADVANTAGE WIRE WAS STRIPPED OFF IN ONE AREA. THEY DID USE WIRE ON THE PATIENT AND THEN IT WAS NOTICED. THERE WAS NO KNOWN HARM TO THE PATIENT; HOWEVER, IT WAS UNKNOWN WHAT HAPPENED TO THAT PORTION OF WIRE COATING. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY/MEDIAL OR SURGICAL INTERVENTION REQUIRED. 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 06 FEB 2024: THE PROCEDURE WAS AN EXCHANGE OF A NEPHROSTOMY TUBE TO A NEPHROURETERAL PLACEMENT. THE SIZE WAS THREE DIFFERENT SPOTS. THE FIRST WAS A VERY SHORT SEGMENT LESS THAN A MILLIMETER (MM). THE SECOND WAS APPROXIMATELY 6MM AND THE THIRD WAS 3-4MM. THERE WAS SOME DIFFICULTY WHEN EXCHANGING ONE CATHETER TO THE NEXT, WHERE IT WAS NOT A SMOOTH TRANSITION OVER THE WIRE. NO TESTING WAS DONE, AND PIECES WERE NOT FOUND. NO INTERVENTION WAS NEEDED. THE PATIENT HAD NO COMPLICATIONS, PATIENT WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659475 ↗
• MalfunctionDec 21, 2023Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THE USER FACILITY REPORTED THAT THE WIRE BECAME UNBRAIDED AND PEELED. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. 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 (B)(6)2023: THE PROCEDURE PERFORMED WAS A PERIPHERAL ANGIOGRAPHY. TO RESOLVE THE ISSUE AND CONTINUE THE PROCEDURE AS PLANNED, THE WIRE WAS EXCHANGED FOR A VERSACORE WIRE. THE DISTAL PORTION WHERE THE BREAKDOWN OF THE WIRE WAS DID NOT ENTER THE PATIENT'S BODY. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY FOR THE PATIENT. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL DEVICES OR EQUIPMENT USED WITH THE REPORTED WIRE WAS A 5 FR UF. IT WAS ATTEMPTED TO BE PLACED OVER WIRE; HOWEVER, THE UF WOULD NOT ADVANCE AND BOTH PRODUCTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371483 ↗
• MalfunctionApr 9, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE BROKE APART DURING A LEG CASE. IT WAS A BAD BIFURCATION WITH A LOT OF CALCIUM. THE DOCTOR THINKS THE GLIDE PORTION BROKE APART WHEN HE PULLED THE WIRE BACK THROUGH THE CALCIUM. THE BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. ADDITIONAL INFORMATION RECEIVED APRIL 1, 2019. THE WIRE DID NOT BREAK APART COMPLETELY. THEY WERE ABLE TO RETRIEVE THE WIRE FROM THE PATIENT COMPLETELY. THE PERIPHERAL INTERVENTION WAS COMPLETED SUCCESSFULLY WITH ANOTHER WIRE.

  Patient problems: No Code Available

  MAUDE report 8495728 ↗