GLIDEWIRE ADVANTAGE TRACK GAT1430Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04987350727886), received between Feb 4, 2020 and Jan 2, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  THE USER FACILITY REPORTED THAT AT THE CONCLUSION OF A SUCCESSFUL FEMORAL ENDARTERECTOMY, THE VASCULAR SURGEON ATTEMPTED TO ACCESS THE PATCH USING A TELEFLEX MICRO PUNCTURE KIT. THE DUAL DILATOR WAS INSERTED THROUGH THE PATCH AND THE SURGEON ATTEMPTED TO MANIPULATE THE DILATOR ANTEGRADE; HOWEVER, HAD CHALLENGES. THE USER REMOVED THE MICRO WIRE AND INSERTED THE GWAT. WHEN RESISTANCE WAS ENCOUNTERED, SHE REMOVED ALL THE EQUIPMENT. THEY THEN NOTICED THE INNER DILATOR WAS BENT AND WHEN THEY TRIED TO REMOVE THE WIRE, IT BEGAN TO SEPARATE. THE TEAM HYPOTHESIZED THAT THE INNER DILATOR BENT WHEN ATTEMPTING TO GUIDE IT ANTEGRADE AND THE GWAT THEN CAUGHT ON THE BEND IN THE DILATOR; HOWEVER, DID NOT SEPARATE UNTIL OUT OF THE PATIENT. THERE WERE NO ADVERSE EVENTS. THE PHYSICIAN ABORTED THE REMAINING ANGIOGRAPHY AND WAS SATISFIED WITH THE OVERALL RESULTS OF THE PROCEDURE. THERE WAS NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055897 ↗
• InjuryOct 12, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHILE ADVANCING AN OTW BOSTON SCIENTIFIC COYOTE BALLOON WHICH WOULD NOT CROSS A LESION, THE COOK 5 FR X 55 CM HYBRID SHEATH BUCKLED IN THE AORTA. THE MD TRIED ADVANCING THE BALLOON WITHOUT THE SHEATH SUPPORT, WHICH LED TO A KINK FORMING IN ON THE GLIDEWIRE ADVANTAGE TRACK .014 WIRE. THE BALLOON WAS REMOVED, AND THE MD PROCEEDED TO TRY AN RX CROSERIO 2 X 200 BALLOON. THE BALLOON MADE IT OVER THE WIRE KINK AND SUCCESSFULLY TREATED THE PERIPHERAL DISEASE IN THE ANTERIOR TIBIAL ARTERY. WHILE REMOVING THE BALLOON, IT WOULDN'T PULL BACK OVER THE WIRE KINK. THIS LED TO THE SHEATH BUCKLING BACK INTO THE AORTA, SO THE MD ADVANCED THE SHEATH WHILE PULLING BALLOON. THIS INCREASED THE KINK IN THE WIRE AND MADE THE BALLOON UNABLE TO BE REMOVED. WITH A REPEATED EFFORT TO PULL THE BALLOON OUT, THE BALLOON SHAFT BROKE AT THE MONORAIL PORT, WHICH LEFT THE BALLOON ON THE SHAFT OF THE WIRE AND THE PROXIMAL BALLOON SHAFT WAS REMOVED. THE MD THEN DECIDED TO DO BILATERAL COMMON FEMORAL ARTERY (CFA) CUTDOWNS TO COMPLETELY REMOVE THE WIRE AND DISTAL MONORAIL BALLOON. THESE WERE SUCCESSFULLY AND ENTIRELY REMOVED AT THIS POINT. MEDICAL OR SURGICAL INTERVENTION REQUIRED. ESTIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928171 ↗
• InjuryOct 12, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHILE ADVANCING AN OTW BOSTON SCIENTIFIC COYOTE BALLOON WHICH WOULD NOT CROSS A LESION, THE COOK 5 FR X 55 CM HYBRID SHEATH BUCKLED IN THE AORTA. THE MD TRIED ADVANCING THE BALLOON WITHOUT THE SHEATH SUPPORT, WHICH LED TO A KINK FORMING IN ON THE GLIDEWIRE ADVANTAGE TRACK .014 WIRE. THE BALLOON WAS REMOVED, AND THE MD PROCEEDED TO TRY AN RX CROSERIO 2 X 200 BALLOON. THE BALLOON MADE IT OVER THE WIRE KINK AND SUCCESSFULLY TREATED THE PERIPHERAL DISEASE IN THE ANTERIOR TIBIAL ARTERY. WHILE REMOVING THE BALLOON, IT WOULDN'T PULL BACK OVER THE WIRE KINK. THIS LED TO THE SHEATH BUCKLING BACK INTO THE AORTA, SO THE MD ADVANCED THE SHEATH WHILE PULLING BALLOON. THIS INCREASED THE KINK IN THE WIRE AND MADE THE BALLOON UNABLE TO BE REMOVED. WITH A REPEATED EFFORT TO PULL THE BALLOON OUT, THE BALLOON SHAFT BROKE AT THE MONORAIL PORT, WHICH LEFT THE BALLOON ON THE SHAFT OF THE WIRE AND THE PROXIMAL BALLOON SHAFT WAS REMOVED. THE MD THEN DECIDED TO DO BILATERAL COMMON FEMORAL ARTERY (CFA) CUTDOWNS TO COMPLETELY REMOVE THE WIRE AND DISTAL MONORAIL BALLOON. THESE WERE SUCCESSFULLY AND ENTIRELY REMOVED AT THIS POINT. MEDICAL OR SURGICAL INTERVENTION REQUIRED. ESTIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928153 ↗
• InjuryDec 29, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS ATTEMPTING TO CROSS A VERY CALCIFIED OCCLUDED PEDAL LOOP WHEN THEY REMOVED THE WIRE IT UNRAVELED, AND THEY NOTED THAT THE TIP OF THE WIRE WAS STILL IN THE PATIENT. IT WAS LEFT BETWEEN THE FIRST AND SECOND TOE. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS A SUCCESS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 03-DECEMBER-2021: THE PROCEDURE WAS A LEFT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. THE WIRE WAS STILL IN THE PATIENTS LEFT FOOT BETWEEN THEIR FIRST AND SECOND TOE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13112881 ↗
• InjuryDec 29, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS ATTEMPTING TO CROSS A VERY CALCIFIED OCCLUDED PEDAL LOOP WHEN THEY REMOVED THE WIRE IT UNRAVELED, AND THEY NOTED THAT THE TIP OF THE WIRE WAS STILL IN THE PATIENT. IT WAS LEFT BETWEEN THE FIRST AND SECOND TOE. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS A SUCCESS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 03DECEMBER2021: THE PROCEDURE WAS A LEFT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. THE WIRE WAS STILL IN THE PATIENTS LEFT FOOT BETWEEN THEIR FIRST AND SECOND TOE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13112876 ↗
• InjuryFeb 4, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DURING A TRIAL OF THE NEW GLIDEWIRE ADVANTAGE TRACK WIRES, ONE OF THE .014 WIRES SNAPPED OFF INSIDE THE PATIENT AFTER ONE PASS. THE WIRE SNAPPED AT THE JOINT AND PUT A SCREECHING HALT TO THE CASE. THE PATIENT'S CONDITION WAS STABLE AND OKAY, THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 16JAN2020. IT WAS A PERIPHERAL INTERVENTION/CLI CASE. THE WIRE ENTERED THE PATIENT THROUGH A 4/5 SLENDER SHEATH IN THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS LOCATED AND STILL IS IN THE PATIENT'S POSTERIOR TIBIAL ARTERY; THE WIRE WAS NOT RETRIEVED. THE DOCTOR HAD TO GAIN ACCESS IN A DIFFERENT VESSEL (THE ANTERIOR TIBIAL) AND FINISHED THE CASE VIA THAT ACCESS SITE. THE WIRE BREAKING OFF IN THE POSTERIOR TIBIAL ARTERY CHANGED WHAT HIS WHOLE GAME PLAN WAS FOR INTERVENTION. THE PATIENT WAS NOT HOSPITALIZED FOR A LONGER PERIOD. ADDITIONAL INFORMATION WAS RECEIVED ON 20JAN2020. THE PATIENT HAD STENOSIS AND CALCIFICATION. THE PATIENT WAS REPORTED TO BE FINE AND THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY. THE LENGTH OF THE WIRE REMAINED INSIDE THE PATIENT WAS 40MM (4CM). THE WIRE SNAPPED APPROXIMATELY 4CM FROM THE DISTAL TIP OF THE WIRE. T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9664528 ↗
• InjuryFeb 4, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DURING A TRIAL OF THE NEW GLIDEWIRE ADVANTAGE TRACK WIRES, ONE OF THE .014 WIRES SNAPPED OFF INSIDE THE PATIENT AFTER ONE PASS. THE WIRE SNAPPED AT THE JOINT AND PUT A SCREECHING HALT TO THE CASE. THE PATIENT'S CONDITION WAS STABLE AND OKAY, THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 16JAN2020. IT WAS A PERIPHERAL INTERVENTION/CLI CASE. THE WIRE ENTERED THE PATIENT THROUGH A 4/5 SLENDER SHEATH IN THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS LOCATED AND STILL IS IN THE PATIENT'S POSTERIOR TIBIAL ARTERY; THE WIRE WAS NOT RETRIEVED. THE DOCTOR HAD TO GAIN ACCESS IN A DIFFERENT VESSEL (THE ANTERIOR TIBIAL) AND FINISHED THE CASE VIA THAT ACCESS SITE. THE WIRE BREAKING OFF IN THE POSTERIOR TIBIAL ARTERY CHANGED WHAT HIS WHOLE GAME PLAN WAS FOR INTERVENTION. THE PATIENT WAS NOT HOSPITALIZED FOR A LONGER PERIOD. ADDITIONAL INFORMATION WAS RECEIVED ON 20JAN2020. THE PATIENT HAD STENOSIS AND CALCIFICATION. THE PATIENT WAS REPORTED TO BE FINE AND THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY. THE LENGTH OF THE WIRE REMAINED INSIDE THE PATIENT WAS 40MM (4CM). THE WIRE SNAPPED APPROXIMATELY 4CM FROM THE DISTAL TIP OF THE WIRE. T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9664527 ↗