GLIDEWIRE ADVANTAGE GA1430Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04987350717924), received between Jul 31, 2018 and Sep 17, 2026 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50801593 ↗
• InjuryMar 18, 2025Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE WIRE WAS STRIPPED. THEY OPENED ANOTHER WIRE TO USE, AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT AND NO BLOOD LOSS. THE PROCEDURE PERFORMED WAS AN ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 25FEB2025: THE ISSUE WAS DISCOVERED INSIDE OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638951 ↗
• InjuryMar 18, 2025Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE WIRE WAS STRIPPED. THEY OPENED ANOTHER WIRE TO USE, AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT AND NO BLOOD LOSS. THE PROCEDURE PERFORMED WAS AN ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 25FEB2025: THE ISSUE WAS DISCOVERED INSIDE OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638950 ↗
• InjuryOct 29, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT AN .018 STRAIGHT NAVICROSS CATHETER WAS ADVANCED IN THE TP TRUNK OVER THE .014 GLIDEWIRE ADVANTAGE. THE PHYSICIAN THEN TRIED TO PASS THE NAVICROSS THROUGH A TIGHT LESION INTO THE PATIENT. THE ADVANTAGE WIRE WAS REMOVED, A .018 PLATINUM PLUS WIRE WAS INSERTED AND REMOVED. HE HAD TROUBLE PUSHING IT OVER THE WIRE. THE PHYSICIAN THEN SAID IT FELT AS IF THE CATHETER POPPED THROUGH. ONCE HE RETRACTED THE NAVICROSS CATHETER BACK INTO THE TP TRUNK, WE SAW REMANENCE OF WHAT APPEARED TO BE THE HYDROPHILIC COATING SLUFF OFF IN THE PATIENT'S VESSEL. IT WAS POSSIBLE THAT THE ADVANTAGE COULD HAVE SLUFFED OFF INSIDE THE .018 NAVICROSS AND THEN LATER EXPOSED IN THE VESSEL ONCE ANOTHER WIRE WAS USED, CAUSING IT TO BE PUSHED OUTSIDE THE CATHETER. THE PHYSICIAN REMOVED THE NAVICROSS FROM THE PATIENT'S VESSEL AND THERE WERE TWO PIECES OF FOREIGN BODY LEFT BEHIND. WE HAD TO SNARE THE TWO PIECES OF BLACK REMANENCE OUT. THE PROCEDURE PERFORMED WAS A PERIPHERAL ANGIOGRAM. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 11OCT2024: THE SAMPLE WAS IN THE BODY AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20559267 ↗
• InjuryOct 29, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT AN .018 STRAIGHT NAVICROSS CATHETER WAS ADVANCED IN THE TP TRUNK OVER THE .014 GLIDEWIRE ADVANTAGE. THE PHYSICIAN THEN TRIED TO PASS THE NAVICROSS THROUGH A TIGHT LESION INTO THE PATIENT. THE ADVANTAGE WIRE WAS REMOVED, A .018 PLATINUM PLUS WIRE WAS INSERTED AND REMOVED. HE HAD TROUBLE PUSHING IT OVER THE WIRE. THE PHYSICIAN THEN SAID IT FELT AS IF THE CATHETER POPPED THROUGH. ONCE HE RETRACTED THE NAVICROSS CATHETER BACK INTO THE TP TRUNK, WE SAW REMANENCE OF WHAT APPEARED TO BE THE HYDROPHILIC COATING SLUFF OFF IN THE PATIENT'S VESSEL. IT WAS POSSIBLE THAT THE ADVANTAGE COULD HAVE SLUFFED OFF INSIDE THE .018 NAVICROSS AND THEN LATER EXPOSED IN THE VESSEL ONCE ANOTHER WIRE WAS USED, CAUSING IT TO BE PUSHED OUTSIDE THE CATHETER. THE PHYSICIAN REMOVED THE NAVICROSS FROM THE PATIENT'S VESSEL AND THERE WERE TWO PIECES OF FOREIGN BODY LEFT BEHIND. WE HAD TO SNARE THE TWO PIECES OF BLACK REMANENCE OUT. THE PROCEDURE PERFORMED WAS A PERIPHERAL ANGIOGRAM. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 11OCT2024: THE SAMPLE WAS IN THE BODY AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20559055 ↗
• MalfunctionOct 8, 2024Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS A RIGHT LEG ATHERECTOMY. THE WIRE STARTED BACKING OUT WHILE TAKING THE BD ROTAREX OUT OF THE PATIENT. THE DEVICE CAME OUT, THEY TOOK PICTURES, AND REMOVED THE WIRE. THE WIRE WAS BROKEN. THE WIRE MADE IT TO THE SHEATH BEFORE IT BROKE ALL THE WAY OFF. THEY RETRIEVED THE WIRE WITH NO COMPLICATIONS. THEY DID NOT HAVE TO USE A SNARE; IT CAME OUT WITH THE SHEATH. THE CASE WAS SUCCESSFUL, AND THE PATIENT DID NOT KNOW ANYTHING WAS WRONG. THEY STATED THEY USE THE ROTAREX ALL THE TIME OVER THE GWA. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23SEP2024: THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397253 ↗
• InjuryDec 6, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE WIRE WAS BEING USED TO CROSS THE SUPERFICIAL FEMORAL ARTERY (SFA) FROM LEFT ANTEGRADE APPROACH. WHILE PUSHING THE WIRE IT SNAPPED AROUND 20CM FROM THE TIP. THE PATIENT HAD 5FR MICRO PUNCTURE ACCESS. THE WIRE WAS INSERTED THROUGH THE MICRO ACCESS SHEATH. THE PATIENT WAS UNDERGOING SURGERY TO REMOVE THE WIRE LEFT IN THE BODY. THE DOCTOR SAID THAT HE WAS PUSHING AND PULLING IN ATTEMPT TO CROSS DOWN BYPASS GRAFT. ANATOMY LOOKED TO BE NORMAL FROM COMMON FEMORAL ARTERY (CFA) TO MID SUPERFICAL FEMORAL ARTERY (SFA). SEVERE PAD NOTICED FROM MID SUPERFICAL FEMORAL ARTERY (SFA) TO DISTAL BYPASS GRAFT. PATIENTS PRE-PROCEDURAL CONDITION WAS PERIPHERAL ARTERY DISEASE (PAD) DIAGNOSIS WITH OCCLUDED BYPASS GRAFT. THE DOCTOR HAD TO PERFORM OPEN REMOVAL OF THE BROKEN WIRE. RELEVANT TESTS AND LAB RESULTS WERE AN ANGIOGRAM ON (B)(6) 2023. TYPE OF PROCEDURE BEING PERFORMED WAS A LEFT ANTEGRADE APPROACH ANGIOGRAM WITH THROMBOLYSIS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDTIONAL INFORMATION WAS RECEIVED ON 18AUG2023: THE PATIENT WAS STABLE AND FOREIGN BODY REMOVAL SURGERY WENT WELL. GUIDEWIRE TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT. AN OPEN SURGICAL FOREI

  Patient problems: Foreign Body In Patient

  MAUDE report 18275080 ↗
• InjuryNov 28, 2023Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF GWA .014 INVOLVED BROKE OFF IN A VERY HEAVY CALCIFIED AREA OF THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS BEING USED THROUGH A FINECROSS M3. WHEN PUSHED MULTIPLE TIMES INTO THE CALCIFIED SEGMENT, THE WIRE TIP BROKE. THE CASE WAS COMPLETED AS NORMAL, AND THE PIECE OF WIRE WAS NOT REMOVED AS IT WAS NOT CAUSING ANY ISSUES WITH THE PATIENT. THE PATIENT CONDITION WAS NOT AFFECTED. THE PROCEDURE OUTCOME WAS NOT AFFECTED. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 08 DEC 2022: THE CASE WAS A CLI CASE FOR A NON-HEALING WOUND ON THE PATIENT'S HEEL. THERE WAS NO BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION AND WAS NOT AFFECTED; HOWEVER, THE TIP OF THE WIRE WAS LEFT BEHIND.

  Patient problems: Foreign Body In Patient

  MAUDE report 18219267 ↗
• InjurySep 7, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE ADVANTAGE WAS BEING USED TO CROSS THE SUPERFICIAL FEMORAL ARTERY (SFA) FROM LEFT ANTEGRADE APPROACH. WHILE PUSHING THE WIRE IT SNAPPED AROUND 20 CM FROM THE TIP. THE PATIENT HAD 5FR MICRO PUNCTURE ACCESS. THE WIRE WAS INSERTED THROUGH THE MICRO ACCESS SHEATH. THE PATIENT WAS UNDERGOING SURGERY TO REMOVE THE WIRE LEFT IN THE BODY. THE DOCTOR SAID THAT HE WAS PUSHING AND PULLING IN ATTEMPT TO CROSS DOWN BYPASS GRAFT. ANATOMY LOOKED TO BE NORMAL FROM THE COMMON FEMORAL ARTERY (CFA) TO MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE PERIPHERAL ARTERY DISEASE (PAD) WAS NOTICED FROM MID SUPERFICIAL FEMORAL ARTERY (SFA) TO DISTAL BYPASS GRAFT. PATIENTS PRE-PROCEDURAL CONDITION WAS PERIPHERAL ARTERY DISEASE (PAD) DIAGNOSIS WITH OCCLUDED BYPASS GRAFT. PATIENT INJURY AND/OR SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE DOCTOR HAD TO PERFORM OPEN REMOVAL OF THE BROKEN WIRE. RELEVANT TESTS AND LAB RESULTS WERE AN ANGIOGRAM ON (B)(6) 2023. THE TYPE OF PROCEDURE BEING PERFORMED WAS A LEFT ANTEGRADE APPROACH ANGIOGRAM WITH THROMBOLYSIS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 18AUG2023: THE PATIENT WAS ST

  Patient problems: Foreign Body In Patient

  MAUDE report 17706885 ↗
• InjuryDec 29, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF GWA .014 INVOLVED BROKE OFF IN A VERY HEAVY CALCIFIED AREA OF THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS BEING USED THROUGH A FINECROSS M3. WHEN PUSHED MULTIPLE TIMES INTO THE CALCIFIED SEGMENT, THE WIRE TIP BROKE. THE CASE WAS COMPLETED AS NORMAL, AND THE PIECE OF WIRE WAS NOT REMOVED AS IT WAS NOT CAUSING ANY ISSUES WITH THE PATIENT. THE PATIENT CONDITION WAS NOT AFFECTED. THE PROCEDURE OUTCOME WAS NOT AFFECTED. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 08 DEC 2022: THE CASE WAS A CLI CASE FOR A NON-HEALING WOUND ON THE PATIENT'S HEEL. THERE WAS NO BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION AND WAS NOT AFFECTED; HOWEVER, THE TIP OF THE WIRE WAS LEFT BEHIND.

  Patient problems: Foreign Body In Patient

  MAUDE report 16070952 ↗
• MalfunctionJul 28, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS PERFORMING STANDARD ANGIOPLASTY OVER THE .014 GUIDEWIRE ADVANTAGE (GWA) AND THE WIRE STARTED TO PEEL APART ALMOST AND DISINTEGRATE. THE PATIENT HAD NO ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 10 JULY 2022: NONE OF THE WIRE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS STABLE. ANOTHER .014 WIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127279 ↗
• MalfunctionJul 5, 2022Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT THE WIRE BECAME UNRAVELED WHILE BEING USED WITH COOK CXI SUPPORT CATH DURING A PROCEDURE. THERE WAS NO PATIENT INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS UNKNOWN. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED 17 JUN 2022: AN ANGIOGRAM OF THE LEG WAS PERFORMED. THE WIRE WAS STUCK INSIDE AN .014 CXI CATHETER. THEY WERE ABLE TO PULL IT OUT, HOWEVER THE COATING BEGAN TO COME OFF AND WAS NO LONGER SAFE TO PUT BACK INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT OPENING ANOTHER WIRE. ANOTHER .014 GLIDE ADVANTAGE WAS USED TO CROSS THE LESION. NOTHING WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14922857 ↗
• MalfunctionFeb 1, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING A BELOW-THE-KNEE ANGIOPLASTY PROCEDURE THE CIRCULATING TECHNICIAN OPENED THE GA1430 AND THE SCRUB TECH FLUSHED THE HOLDER. UPON PASSING THE DEVICE TO THE PHYSICIAN, IT WAS NOTED THAT THE TIP OF THE WIRE WAS DAMAGED. THE WIRE WAS SET ASIDE AND A NEW GA1430 WAS OPENED AND PREPPED, AND PROCEDURE CONTINUED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S.THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13409437 ↗
• InjuryJan 7, 2022Break; Break

  A MAUDE DATABASE SEARCH CONDUCTED ON 14DECEMBER2021 FOUND A MAUDE REPORT NUMBER MW5105119. THE EVENT DESCRIPTION STATES: "PATIENT HAD A CHOLANGIOGRAM WITH PLACEMENT OF BILIARY DRAINS. ABOUT 6 INCHES OF THE GLIDEWIRE SHEARED OFF DURING THE PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 13195360 ↗
• InjuryJan 7, 2022Break; Break

  A MAUDE DATABASE SEARCH CONDUCTED ON (B)(6) 2021 FOUND A MAUDE REPORT NUMBER MW5105119. THE EVENT DESCRIPTION STATES: "PATIENT HAD A CHOLANGIOGRAM WITH PLACEMENT OF BILIARY DRAINS. ABOUT 6 INCHES OF THE GLIDEWIRE SHEARED OFF DURING THE PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 13195303 ↗
• InjuryJul 31, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED DURING AN OUTPATIENT PROCEDURE, THE RADIFOCUS TC-WIRE V WAS PLACED IN THE DISTAL PART OF THE PATIENT; POST POBA (PLAIN OLD BALLOON ANGIOPLASTY); THE DISTAL TIP OF THE GLIDEWIRE ADVANTAGE SEPARATED/DETACHED FROM THE BODY OF THE WIRE. THIS WAS OBSERVED AND PRESENT THROUGH ANGIOGRAPHY. THE SEPARATED TIP WAS TOO FAR DISTAL TO RETRIEVE VIA SNARE, AND REMAINED IN THE PATIENT. THERE WAS NO THROMBUS WAS PRESENT. THE PROCEDURE OUTCOME WAS GOOD, THE PATIENT WAS IN STABLE CONDITION, AND WAS DISCHARGED THAT SAME DAY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7734964 ↗