GLIDEWIRE GS3506Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04987350773593), received between May 1, 2024 and Nov 25, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Peeled/Delaminated; Peeled/Delaminated

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING A NEPHROURETERECTOMY DRAIN INSERTION, THE COATING ON THE STIFF GLIDEWIRE PEELED OFF INSIDE THE METAL CANNULA STIFFENER FOR THE DRAIN. WE WERE ABLE TO RETRIEVE THE COATING THAT PEELED OFF. THERE WAS NO BLOOD LOSS. THERE WAS NO SERIOUS HARM REPORTED. THE DEVICE DEFECT WAS OBSERVED PRIOR TO USE. THERE WAS NO PROLONGED CARE. ADDITIONAL INFORMATION AS RECEIVED ON 04NOV2025: THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646447 ↗
• InjuryNov 25, 2025Peeled/Delaminated; Peeled/Delaminated

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING A NEPHROURETERECTOMY DRAIN INSERTION, THE COATING ON THE STIFF GLIDEWIRE PEELED OFF INSIDE THE METAL CANNULA STIFFENER FOR THE DRAIN. WE WERE ABLE TO RETRIEVE THE COATING THAT PEELED OFF. THERE WAS NO BLOOD LOSS. THERE WAS NO SERIOUS HARM REPORTED. THE DEVICE DEFECT WAS OBSERVED PRIOR TO USE. THERE WAS NO PROLONGED CARE. ADDITIONAL INFORMATION AS RECEIVED ON 04NOV2025: THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646446 ↗
• InjuryJul 23, 2025Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS COMPLICATED BY A FRACTURED GUIDEWIRE WITH THE GUIDEWIRE FRAGMENT LODGED IN A SUBINTIMAL LOCATION ALONG THE LEFT ILIAC ARTERY. THE ATTEMPTS TO SNARE AND REMOVE THE FRAGMENT WERE NOT SUCCESSFUL. EVENTUALLY, THEY DECIDED THAT THE SAFEST THING FOR THE PATIENT WAS TO LEAVE THE WIRE FRAGMENT IN PLACE. THE FRAGMENT WOULD HAVE BEEN SECURED BY ITS SUBINTIMAL LOCATION. THE WIRE FRAGMENT WAS FURTHER SECURED WITH THE DEPLOYMENT OF ADJACENT BALLOON-EXPANDABLE STENTS. THE PROCEDURE WAS ARTERIAL ANGIOPLASTY AND ATHERECTOMY. NO BLOOD LOSS WAS REPORTED. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 14JUL2025: THE SIZE OF FRAGMENT LEFT IN PATIENT WAS 13 CM. WITHIN A SUBINTIMAL TRACT WITH TORTUOSITY AND RESISTANCE WITH TORQUE APPLIED TO THE WIRE USING A TORQUE DEVICE. THE WIRE HAD BEEN ADVANCED THROUGH 5F KUMPE AND OMNI SELECT CATHETERS. THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO PLANS TO REMOVE WIRE FRAGMENTS SINCE THEY PLACED STENTS TO SECURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22578816 ↗
• InjuryJul 23, 2025Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS COMPLICATED BY A FRACTURED GUIDEWIRE WITH THE GUIDEWIRE FRAGMENT LODGED IN A SUBINTIMAL LOCATION ALONG THE LEFT ILIAC ARTERY. THE ATTEMPTS TO SNARE AND REMOVE THE FRAGMENT WERE NOT SUCCESSFUL. EVENTUALLY, THEY DECIDED THAT THE SAFEST THING FOR THE PATIENT WAS TO LEAVE THE WIRE FRAGMENT IN PLACE. THE FRAGMENT WOULD HAVE BEEN SECURED BY ITS SUBINTIMAL LOCATION. THE WIRE FRAGMENT WAS FURTHER SECURED WITH THE DEPLOYMENT OF ADJACENT BALLOON-EXPANDABLE STENTS. THE PROCEDURE WAS ARTERIAL ANGIOPLASTY AND ATHERECTOMY. NO BLOOD LOSS WAS REPORTED. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 14JUL2025: THE SIZE OF FRAGMENT LEFT IN PATIENT WAS 13 CM. WITHIN A SUBINTIMAL TRACT WITH TORTUOSITY AND RESISTANCE WITH TORQUE APPLIED TO THE WIRE USING A TORQUE DEVICE. THE WIRE HAD BEEN ADVANCED THROUGH 5F KUMPE AND OMNI SELECT CATHETERS. THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO PLANS TO REMOVE WIRE FRAGMENTS SINCE THEY PLACED STENTS TO SECURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22578595 ↗
• InjurySep 27, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A VASCULAR PROCEDURE IN IR, THE TIP OF THE STIFF ANGLED GLIDEWIRE BROKE OFF IN A COLLATERAL VESSEL. THE TIP COULD NOT BE RETRIEVED BEFORE THE END OF THE PROCEDURE. THERE WAS NO BLOOD LOSS REPORTED. THE INJURY INVOLVED THE TIP OF THE GLIDEWIRE BREAKING OFF AND BEING LEFT INSIDE A COLLATERAL ARTERY. NO DIRECT ALLEGATION HAS BEEN MADE. PRE-PROCEDURE CONDITION: THE PATIENT PRESENTED WITH PROLONGED BLEEDING DURING DIALYSIS TREATMENTS. AN ANGIOGRAM CONFIRMED A TOTAL CEPHALIC ARCH OCCLUSION. ADDITIONAL INFORMATION WAS RECEIVED ON 3 SEPT 2024: THERE WAS NO HARM TO THE PATIENT'S VESSEL. THE PHYSICIAN ATTEMPTED TO CROSS A TOTAL OCCLUSION IN THE PATIENT'S CEPHALIC ARCH. ALTHOUGH THE OCCLUSION WAS NOT CROSSED, NO HARM WAS CAUSED. THE TIP WAS LEFT IN THE STENOSIS AS IT IS IN A STABLE POSITION WITH LITTLE RISK OF MIGRATION. THE PATIENT IS STABLE AND EXPERIENCED NO ADVERSE EFFECTS FROM THE EVENT. THE SAMPLE WAS IN THE BODY AND IN CONTACT WITH BLOOD BUT WAS WIPED OFF BEFORE COLLECTION. IT IS NOT CONTAMINATED BY INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20317344 ↗
• InjurySep 26, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A VASCULAR PROCEDURE IN IR, THE TIP OF THE STIFF ANGLED GLIDEWIRE BROKE OFF IN A COLLATERAL VESSEL. THE TIP COULD NOT BE RETRIEVED BEFORE THE END OF THE PROCEDURE. THERE WAS NO BLOOD LOSS REPORTED. THE INJURY INVOLVED THE TIP OF THE GLIDEWIRE BREAKING OFF AND BEING LEFT INSIDE A COLLATERAL ARTERY. NO DIRECT ALLEGATION HAS BEEN MADE. PRE-PROCEDURE CONDITION: THE PATIENT PRESENTED WITH PROLONGED BLEEDING DURING DIALYSIS TREATMENTS. AN ANGIOGRAM CONFIRMED A TOTAL CEPHALIC ARCH OCCLUSION. ADDITIONAL INFORMATION WAS RECEIVED ON 3 SEPT 2024: THERE WAS NO HARM TO THE PATIENT'S VESSEL. THE PHYSICIAN ATTEMPTED TO CROSS A TOTAL OCCLUSION IN THE PATIENT'S CEPHALIC ARCH. ALTHOUGH THE OCCLUSION WAS NOT CROSSED, NO HARM WAS CAUSED. THE TIP WAS LEFT IN THE STENOSIS AS IT IS IN A STABLE POSITION WITH LITTLE RISK OF MIGRATION. THE PATIENT IS STABLE AND EXPERIENCED NO ADVERSE EFFECTS FROM THE EVENT. THE SAMPLE WAS IN THE BODY AND IN CONTACT WITH BLOOD BUT WAS WIPED OFF BEFORE COLLECTION. IT IS NOT CONTAMINATED BY INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20312966 ↗
• InjuryMay 1, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT WHEN TORQUING THE INVOLVED GUIDEWIRE (GW), THE DISTAL ANGLED PORTION OF THE GW BROKE OFF AND REMAINED IN THE PATIENT. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT RESULTED 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. ADDITIONAL INFORMATION WAS RECEIVED ON 16APR2024: THE PROCEDURE PERFORMED WAS A BILATERAL PELVIC ANGIOGRAM. THERE WAS NO INTERVENTION PERFORMED WHEN THE WIRE BROKE OFF, THE PHYSICIAN WAS ATTEMPTING TO CROSS A LESION. THERE WAS NO MORE RESISTANCE THAN WHAT WAS TO BE EXPECTED. THE BROKEN PIECE WAS NOT REMOVED FROM THE PATIENT, IT WAS IN THE RETROPERITONEAL SOFT TISSUE. THE PIECE REMAINED IN THE PATIENT. THE PATIENT WAS STABLE. THE PROCEDURE WAS NOT COMPLETED AT THAT TIME DUE TO PATIENT TOLERANCE. THE PATIENT NEEDED ANESTHESIA AND THE PROCEDURE WAS COMPLETED A DIFFERENT DAY WITH GENERAL ANESTHESIA. THE DEVICE DID NOT APPEAR TO BE DAMAGED PRIOR TO USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19220780 ↗
• InjuryMay 1, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT WHEN TORQUING THE INVOLVED GUIDEWIRE (GW), THE DISTAL ANGLED PORTION OF THE GW BROKE OFF AND REMAINED IN THE PATIENT. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT RESULTED 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. ADDITIONAL INFORMATION WAS RECEIVED ON 16APR2024: THE PROCEDURE PERFORMED WAS A BILATERAL PELVIC ANGIOGRAM. THERE WAS NO INTERVENTION PERFORMED WHEN THE WIRE BROKE OFF, THE PHYSICIAN WAS ATTEMPTING TO CROSS A LESION. THERE WAS NO MORE RESISTANCE THAN WHAT WAS TO BE EXPECTED. THE BROKEN PIECE WAS NOT REMOVED FROM THE PATIENT, IT WAS IN THE RETROPERITONEAL SOFT TISSUE. THE PIECE REMAINED IN THE PATIENT. THE PATIENT WAS STABLE. THE PROCEDURE WAS NOT COMPLETED AT THAT TIME DUE TO PATIENT TOLERANCE. THE PATIENT NEEDED ANESTHESIA AND THE PROCEDURE WAS COMPLETED A DIFFERENT DAY WITH GENERAL ANESTHESIA. THE DEVICE DID NOT APPEAR TO BE DAMAGED PRIOR TO USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19220610 ↗