GLIDEWIRE ADVANTAGERecalls & reported problems across all models

We found 5 models of GLIDEWIRE ADVANTAGE by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2017 and Sep 17, 2026 — classified as 47 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Separation” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GLIDEWIRE ADVANTAGE problems

GLIDEWIRE ADVANTAGE models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GLIDEWIRE ADVANTAGE GA3502

  WIRE, GUIDE, CATHETER
  32 reports
• GLIDEWIRE ADVANTAGE GA1830

  WIRE, GUIDE, CATHETER
  19 reports
• GLIDEWIRE ADVANTAGE GA1430

  WIRE, GUIDE, CATHETER
  16 reports
• GLIDEWIRE ADVANTAGE GA3501

  WIRE, GUIDE, CATHETER
  6 reports
• GLIDEWIRE ADVANTAGE GA1818

  WIRE, GUIDE, CATHETER
  6 reports

Recent GLIDEWIRE ADVANTAGE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50801593 ↗
• 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 ↗
• InjuryMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE THE WIRE WAS BEING USED IN THE PROCEDURE, THE TIP OF THE WIRE BROKE ROUGHLY 10CM FROM THE DISTAL TIP. THE PHYSICIAN SAID THAT HE WAS IN A HEAVILY CALCIFIED VESSEL AND WAS TORQUING THE WIRE BEFORE IT BROKE. A NEW WIRE WAS OPENED AND THE CASE WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 09FEB2026: THERE WAS A FRAGMENT LEFT IN THE PATIENT'S BODY. THE FRAGMENTS WERE LEFT IN THE VESSEL AS THE PATIENT WILL NEED BYPASS AND THE ARTERY THE TIP BROKE OFF IN IS COMPLETELY OCCLUDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24491724 ↗
• InjuryMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE THE WIRE WAS BEING USED IN THE PROCEDURE, THE TIP OF THE WIRE BROKE ROUGHLY 10CM FROM THE DISTAL TIP. THE PHYSICIAN SAID THAT HE WAS IN A HEAVILY CALCIFIED VESSEL AND WAS TORQUING THE WIRE BEFORE IT BROKE. A NEW WIRE WAS OPENED AND THE CASE WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 09FEB2026: THERE WAS A FRAGMENT LEFT IN THE PATIENT'S BODY. THE FRAGMENTS WERE LEFT IN THE VESSEL AS THE PATIENT WILL NEED BYPASS AND THE ARTERY THE TIP BROKE OFF IN IS COMPLETELY OCCLUDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24491722 ↗
• MalfunctionJan 8, 2026

  FROM STAFF: UPON REMOVING THE 0.035" 260CM GLIDEWIRE ADVANTAGE FROM THE RIGHT GROIN, IT WAS FOUND THAT THE FLOPPY DISTAL END CAME LOOSE FROM THE WIRE (WITHOUT COMING OFF COMPLETELY), EXPOSING THE BARE METAL END. PRODUCT WAS REMOVED FROM FIELD AND GIVEN TO TEAM LEADER. UNSURE OF WHAT COULD HAVE CAUSE THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002937 ↗
• InjuryNov 6, 2025Material Frayed; Material Frayed

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE GLIDEWIRE ADVANTAGE WAS USED ON THE PATIENT; HOWEVER, THE TIP BECAME FRAYED. THE PROCEDURE PERFORMED WAS AN LLE, AND NO BLOOD LOSS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23490439 ↗
• InjuryOct 27, 2025Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5175307. THE EVENT DESCRIPTION STATES: "GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON (B)(6). WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME, WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 23398615 ↗
• InjuryOct 27, 2025Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON (B)(6). WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME, WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 23398613 ↗
• InjurySep 9, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS A PERIPHERAL INTERVENTION ON THE ANTERIOR TIBIAL VESSEL OF THE LEFT LEG VIA RIGHT GROIN ACCESS. A 6 FRENCH DESTINATION SHEATH WAS ADVANCED UP AND OVER THE ILIAC BIFURCATION. THE 018 GWA WAS ADVANCED ACROSS TWO HEAVILY CALCIFIED LESIONS. AN 018 NAVICROSS WAS ADVANCED OVER THE WIRE WITH INTENTION OF WIRE EXCHANGE FOR THE VIPER WIRE. WHEN THE PHYSICIAN PULLED BACK ON THE WIRE, THERE WAS MUCH RESISTANCE. THEY WERE UNABLE TO CAPTURE THE WIRE IN THE NAVICROSS. NAVICROSS WAS REMOVED LEAVING WIRE IN THE ANTERIOR TIBIAL VESSEL. THE PHYSICIAN CARRIED ON WITH THE PROCEDURE AND THE PROCEDURE WAS A SUCCESS. AT THE END, THE PHYSICIAN WAS ABLE TO SAFELY REMOVE THE WIRE. ON REMOVAL, THE WIRE APPEARED TO HAVE BEEN STRIPPED OF THE PLASTIC JACKET TOWARD THE DISTAL END OF THE WIRE. ALL PARTS OF THE PLASTIC JACKET WERE INTACT. THEY ARE CRIMPED UP AT THE TIP AND NITINOL INTERNAL WIRE EXPOSED. THE PHYSICIANS' ASSESSMENT WAS THAT THE WIRE WAS PINNED AND STRIPPED BETWEEN TWO CHUNKS OF CALCIUM. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 25JUL2025: THE PATIENT WAS STABLE, AND THE CASE WAS A COMPLETE SUCCESS. THE WIRE WAS UNABLE TO TRACK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006656 ↗
• 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 ↗
• InjuryAug 7, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS A PERIPHERAL INTERVENTION ON THE ANTERIOR TIBIAL VESSEL OF THE LEFT LEG VIA RIGHT GROIN ACCESS. A 6 FRENCH DESTINATION SHEATH WAS ADVANCED UP AND OVER THE ILIAC BIFURCATION. THE 018 GWA WAS ADVANCED ACROSS TWO HEAVILY CALCIFIED LESIONS. AN 018 NAVICROSS WAS ADVANCED OVER THE WIRE WITH INTENTION OF WIRE EXCHANGE FOR THE VIPER WIRE. WHEN THE PHYSICIAN PULLED BACK ON THE WIRE, THERE WAS MUCH RESISTANCE. THEY WERE UNABLE TO CAPTURE THE WIRE IN THE NAVICROSS. NAVICROSS WAS REMOVED LEAVING WIRE IN THE ANTERIOR TIBIAL VESSEL. THE PHYSICIAN CARRIED ON WITH THE PROCEDURE AND THE PROCEDURE WAS A SUCCESS. AT THE END, THE PHYSICIAN WAS ABLE TO SAFELY REMOVE THE WIRE. ON REMOVAL, THE WIRE APPEARED TO HAVE BEEN STRIPPED OF THE PLASTIC JACKET TOWARD THE DISTAL END OF THE WIRE. ALL PARTS OF THE PLASTIC JACKET WERE INTACT. THEY ARE CRIMPED UP AT THE TIP AND NITINOL INTERNAL WIRE EXPOSED. THE PHYSICIANS' ASSESSMENT WAS THAT THE WIRE WAS PINNED AND STRIPPED BETWEEN TWO CHUNKS OF CALCIUM. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 25JUL2025: THE PATIENT WAS STABLE, AND THE CASE WAS A COMPLETE SUCCESS. THE WIRE WAS UNABLE TO TRACK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737690 ↗
• InjuryAug 3, 2025Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD A PERIPHERAL CASE WITH AN UP AN OVER TECHNIQUE BY ACCESSING CONTRALATERAL SIDE TO TAKE WIRE UP AND OVER THE CORINA INTO THE OPPOSITE ILIAC. THE WIRE BROKE WHILE ACROSS THE STEEP BIFURCATING COMMON ILIAC. THE WIRE BROKE INTO TWO PIECES. THE PART WHERE THE WIRE BROKE WAS AT THE METAL AREA PROXIMAL TO THE HYDROPHILIC PART OF THE WIRE. THE DISTAL BROKEN PART OF THE WIRE REMAINED IN THE BODY WHEN PULLING THE WIRE BACK FROM CATHETER AND PART OF THE WIRE REMAINED IN THE CATHETER. THE WIRE WAS REMOVED VIA A CUT DOWN OF THE OTHER SIDE COMMON FEMORAL ARTERY (CFA) AND THE CASE WAS COMPLETED THROUGH A CUT DOWN ENDODARCTOMY OF THE COMMON FEMORAL ARTERY (CFA) AND A ENDOVASCULAR REPAIR AND REVASCULARIZATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH THE CUT DOWN OF THE COMMON FEMORAL ARTERY (CFA). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Foreign Body In Patient

  MAUDE report 22696657 ↗
• InjuryAug 3, 2025Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD A PERIPHERAL CASE WITH AN UP AN OVER TECHNIQUE BY ACCESSING CONTRALATERAL SIDE TO TAKE WIRE UP AND OVER THE CORINA INTO THE OPPOSITE ILIAC. THE WIRE BROKE WHILE ACROSS THE STEEP BIFURCATING COMMON ILIAC. THE WIRE BROKE INTO TWO PIECES. THE PART WHERE THE WIRE BROKE WAS AT THE METAL AREA PROXIMAL TO THE HYDROPHILIC PART OF THE WIRE. THE DISTAL BROKEN PART OF THE WIRE REMAINED IN THE BODY WHEN PULLING THE WIRE BACK FROM CATHETER AND PART OF THE WIRE REMAINED IN THE CATHETER. THE WIRE WAS REMOVED VIA A CUT DOWN OF THE OTHER SIDE COMMON FEMORAL ARTERY (CFA) AND THE CASE WAS COMPLETED THROUGH A CUT DOWN ENDODARCTOMY OF THE COMMON FEMORAL ARTERY (CFA) AND A ENDOVASCULAR REPAIR AND REVASCULARIZATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH THE CUT DOWN OF THE COMMON FEMORAL ARTERY (CFA). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Foreign Body In Patient

  MAUDE report 22696656 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE WIRE BEGAN TO UNRAVEL NEAR THE TIP DURING THE PROCEDURE. NO ATTEMPTS WERE MADE TO SHAPE THE WIRE. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS AND NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 03APR2025: THE TERUMO TERRITORY MANAGER LOOKED AT THE DEVICE AND HE DID NOT SEE ANY DAMAGE TO THE TIP OF THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906176 ↗

Other Terumo Corporation products

• CAPIOXFX12 models · 328 reports
• GLIDEWIRE30 models · 194 reports
• RUNTHROUGH7 models · 170 reports
• CAPIOXRX9 models · 162 reports
• GLIDECATH9 models · 57 reports
• R2P MISAGO13 models · 54 reports
• NAVICROSS11 models · 49 reports
• GUIDE WIRE M6 models · 37 reports