GLIDEWIRE GS3508Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04987350773630), received between Oct 25, 2016 and Sep 8, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Unraveled Material; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678678 ↗
• InjurySep 2, 2025Break; Break

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO RE-CANNULATE THE PATIENT'S CHRONICALLY OCCLUDED INNOMINATE VEINS. THE PHYSICIAN WAS ATTEMPTING TO RE-CANNULATE THE RIGHT INNOMINATE VIA FEMORAL VENOUS ACCESS. WHEN THE PHYSICIAN WAS WITHIN THE OCCLUSION, USING THE STIFF ANGLED GLIDEWIRE, HE PULLED BACK ON THE WIRE, AND APPROXIMATELY 40MM OF THE TIP OF THE WIRE BROKE OFF INTO THE OCCLUSION. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE TIP OF THE WIRE, AS HE BELIEVED HE WOULD NOT BE SUCCESSFUL IN THE RE-CANNULIZATION, AND THE WIRE WAS COMPLETELY WITHIN THE OCCLUDED SEGMENT AND WOULD NOT BE HARMFUL TO THE PATIENT. HE THEN ATTEMPTED TO RECANALIZE THE LEFT INNOMINATE VEIN AND WAS SUCCESSFUL. A STENT WAS PLACED FROM THE LEFT INNOMINATE INTO THE SUPERIOR VENA CAVA (SVC), CROSSING THE RIGHT INNOMINATE WHERE THE WIRE WAS. THE PATIENT REMAINED STABLE THROUGHOUT AND THE PROCEDURE WAS A SUCCESS. THE PROCEDURE WAS A SUPERIOR VENA CAVA RECAN. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 06AUG2025: THE BROKEN WIRE WAS LEFT IN THE PATIENT, AND NO ATTEMPT WAS MADE TO RETRIEVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22931752 ↗
• InjurySep 2, 2025Break; Break

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO RE-CANNULATE THE PATIENT'S CHRONICALLY OCCLUDED INNOMINATE VEINS. THE PHYSICIAN WAS ATTEMPTING TO RE-CANNULATE THE RIGHT INNOMINATE VIA FEMORAL VENOUS ACCESS. WHEN THE PHYSICIAN WAS WITHIN THE OCCLUSION, USING THE STIFF ANGLED GLIDEWIRE, HE PULLED BACK ON THE WIRE, AND APPROXIMATELY 40MM OF THE TIP OF THE WIRE BROKE OFF INTO THE OCCLUSION. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE TIP OF THE WIRE, AS HE BELIEVED HE WOULD NOT BE SUCCESSFUL IN THE RE-CANNULIZATION, AND THE WIRE WAS COMPLETELY WITHIN THE OCCLUDED SEGMENT AND WOULD NOT BE HARMFUL TO THE PATIENT. HE THEN ATTEMPTED TO RECANALIZE THE LEFT INNOMINATE VEIN AND WAS SUCCESSFUL. A STENT WAS PLACED FROM THE LEFT INNOMINATE INTO THE SUPERIOR VENA CAVA (SVC), CROSSING THE RIGHT INNOMINATE WHERE THE WIRE WAS. THE PATIENT REMAINED STABLE THROUGHOUT AND THE PROCEDURE WAS A SUCCESS. THE PROCEDURE WAS A SUPERIOR VENA CAVA RECAN. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 06AUG2025: THE BROKEN WIRE WAS LEFT IN THE PATIENT, AND NO ATTEMPT WAS MADE TO RETRIEVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22931465 ↗
• MalfunctionOct 17, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE WIRE WAS OUTSIDE OF THE PATIENT AND NEVER WENT IN THE PATIENT. THE TORQUER AROUND THE WIRE CREATED TOO MUCH SHEERING FORCE, POSSIBLY, THAT IT TOOK PART OF THE GLIDEWIRE COATING OFF THE WIRE. THE PHYSICIAN DID NOT CLAMP DOWN SUPER HARD, OR AT LEAST ANY MORE THAN USUAL, IN THE AREA WHERE TORQUE WAS SEATED; HOWEVER, WHEN HE UNDID TORQUER, HE NOTICED THE COATING WORE OFF. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 10OCT2024: THE PROCEDURE TOOK PLACE IN THE CATH LAB, THEREFORE WAS A CATHETERIZATION PROCEDURE. THEY RESOLVED THE ISSUE BY USING A SECOND SAME WIRE TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE, AND THE INVOLVED WIRE NEVER ENTERED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471919 ↗
• InjuryAug 16, 2023Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED MEDWATCH REPORT MW5119235. THE EVENT DESCRIPTION STATES: "A PIECE OF THE GLIDEWIRE FRACTURED IN THE PATIENT AND UNABLE TO RETRIEVE."

  Patient problems: Foreign Body In Patient

  MAUDE report 17560542 ↗
• InjuryAug 16, 2023Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED MEDWATCH REPORT MW5119235. THE EVENT DESCRIPTION STATES: "A PIECE OF THE GLIDEWIRE FRACTURED IN THE PATIENT AND UNABLE TO RETRIEVE."

  Patient problems: Foreign Body In Patient

  MAUDE report 17560422 ↗
• InjuryFeb 21, 2023Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "PATIENT IS AN ADULT MALE WITH MEDICAL H/O SIGNIFICANT FOR MORBID OBESITY, EF 20-25% AND HYPOTHYROIDISM WHO PRESENTED TO THE ED WITH SUDDEN ONSET CHEST PAIN. DUE TO POST VF ARREST WITH KNOWN NON-ISCHEMIC CARDIOMYOPATHY, AN ICD WAS INDICATED. PATIENT UNDERWENT PROCEDURE FOR DUAL CHAMBER ICD IMPLANTATION. DIFFICULTIES WERE ENCOUNTERED ADVANCING THE WIRE; THUS, A SLIPPERY GUIDEWIRE WAS USED, AND THE DISTAL END WAS SHEARED OFF LIKELY EXTRA VASCULARLY, ATTEMPTS TO REMOVE IT WAS NOT SUCCESSFUL. FLUOROSCOPY COMPLETED AFTER PROCEDURE AND WAS NOT ABLE TO PICK UP WIRE. VENOGRAM ALSO COMPLETED AND CONFIRMED WIRE WAS NOT IN VEIN. OUTCOME: LIKELY WILL HAVE MINIMAL TO NO IMPACT TO PATIENT. PATIENT WILL FOLLOW UP WITH PHYSICIAN AS OUTPATIENT. THE ORIGINAL INTENDED PROCEDURE WAS AN ICD IMPLANTATION. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: MORBIDLY OBESE." ADDITIONAL INFORMATION WAS RECEIVED ON 31 JAN 2023: THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGICAL INTERVENTION WAS NOT PERFORMED. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE PRO

  Patient problems: Foreign Body In Patient

  MAUDE report 16410533 ↗
• InjuryFeb 21, 2023Material Separation; Material Separation

  TERUMO TMC PERFORMED A MAUDE SEARCH ON (B)(6) 2023. REPORT NUMBER (B)(4) WAS FOUND AND WAS CONFIRMED TO BE OF THE SAME REPORTED EVENT, AND THEREFORE THE MAUDE REPORT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16410442 ↗
• InjuryOct 10, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF WIRE BROKE OFF INSIDE THE PATIENT. THE TIP WAS SNARED, AND THE PATIENT WAS NOT INJURED. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 16-SEPT-2021. FLUORO WAS USED TO CONFIRM THAT THERE WERE NO REMAINING PARTICLES LEFT IN THE PATIENT. THE PROCEDURE PERFORMED WAS AN AORTOILIAC PROCEDURE. THE PATIENT HAS ECCENTRIC PLAQUE & HEAVILY CALCIFIED OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602640 ↗
• InjuryOct 10, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF WIRE BROKE OFF INSIDE THE PATIENT. THE TIP WAS SNARED, AND THE PATIENT WAS NOT INJURED. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 16SEPT2021. FLUORO WAS USED TO CONFIRM THAT THERE WERE NO REMAINING PARTICLES LEFT IN THE PATIENT. THE PROCEDURE PERFORMED WAS AN AORTOILIAC PROCEDURE. THE PATIENT HAS ECCENTRIC PLAQUE & HEAVILY CALCIFIED OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602639 ↗
• MalfunctionNov 20, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE WAS USED DURING THE PROCEDURE. THE WIRE LOST ITS COATING DURING A LONG CASE. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 08NOV2020. IT WAS AN SVC STENTING CASE. PHOTO PROVIDED SHOWING WIRE EXPOSED WHERE COATING APPEARS TO BE MISSING. ADDITIONAL INFORMATION WAS RECEIVED ON 09NOV2020. THERE WAS NO WIRE COATING LEFT IN THE PATIENT, IT FELT MOSTLY PUSHED ALONG/UP ON THE WIRE ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10876545 ↗
• MalfunctionJul 23, 2020Degraded; Degraded

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS WAS USED DURING THE PROCEDURE. DURING USE FOR THE GJ TUBE EXCHANGE, ONCE THE WIRE ENTERED THE GJ TRACT IN LESS THAN TWO MINUTES, THE HYDROPHILIC COATING WORE OFF. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 07JUL2020. THE COATING OF GLIDEWIRE DID NOT SHEAR OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313996 ↗
• InjuryMay 23, 2019Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5086001. THE EVENT DESCRIPTION STATES: "DURING INSERTION OF HEMODIALYSIS CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN, A PIECE OF THE HYDROPHILIC COATING FRAYED OFF THE GUIDE WIRE. THE PIECE BECAME ATTACHED TO THE WALL OF THE INTERNAL JUGULAR VEIN. MULTIPLE ATTEMPTS TO REMOVE THE PIECE WAS ATTEMPTED USING MULTIPLE SNARE WIRES. ALL ATTEMPTS FAILED".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8636301 ↗
• InjuryJan 30, 2019Material Separation; Material Separation

  THIS REPORT IS BEING SUBMITTED IN RESPONSE TO FDA MW5082281. THE USER FACILITY REPORTED THAT THE COATING OVER THE GUIDEWIRE APPEARED TO BE SHEARED OFF DURING THE PROCEDURE. THIS WAS RETRIEVED DURING AN INTERVENTIONAL RADIOLOGY (IR) INTERVENTION. ON THE PACKAGE THERE IS A CAUTIONARY STATEMENT: "DO NOT USE WITH METAL ENTRY NEEDLE." REQUEST OF MANUFACTURER TO HIGHLIGHT AND ENLARGE THE CAUTIONARY STATEMENT ON THE PACKAGE.

  Patient problems: No Code Available

  MAUDE report 8289601 ↗
• InjuryApr 23, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED PER MEDWATCH (B)(4) WHILE SNARING A WIRE, A PIECE OF THE WIRE BROKE OFF IN THE PATIENT. THIS WAS NOTED AFTER THE STENTS WERE PLACED. THE WIRE CAN BE SEEN ON FLUOROSCOPY AND IT IS BELIEVED TO BE BETWEEN TWO STENTS. THE SURGEON BELIEVES IT IS BETTER TO NOT REMOVE THE WIRE, IT WILL NOT MIGRATE. DUE TO THE LENGTH OF THE PROCEDURE, THE DOCTOR STATED IT IS BETTER TO LEAVE IT IN AND MAYBE COME BACK AT A LATER DATE TO PERFORM AN IVUS ON THE PATIENT. THE ORIGINAL PROCEDURE WAS A STENT PLACEMENT. AN X-RAY WAS OBTAINED FOR THE RECORD. PER MEDWATCH ADDITIONAL INFORMATION: THE GUIDEWIRE WAS LEFT IN PLACE AS IT WAS LODGED BETWEEN TWO GRAFTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7450525 ↗
• MalfunctionOct 9, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED GW LOST A LAYER OF THE WIRE IN A SEGMENT OF THE WIRE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) THERE WAS NO COMPLAINT OF INJURY TO PATIENT DUE TO THE GW; AND (2) THE PATIENT WAS REFERRED FOR FURTHER PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED ON 09/29/2017. IT WAS REPORTED THAT THE PATIENT WAS STABLE. THEY WERE ABLE TO FIND THE SEGMENT OF THE WIRE THAT WAS LOST, IT DID NOT COME OFF INSIDE THE PATIENT. THE PROCEDURE WAS NOT SUCCESSFUL. CUSTOMER STATED THIS WAS NOTHING TO DO WITH THE REPORTED PRODUCT, IT WAS A DIFFICULT CASE AND THE PATIENT REQUIRED SURGERY VERSES ENDOVASCULAR INTERVENTION. THE PATIENT BEING REFERRED FOR FURTHER PROCEDURES WAS NOT DUE TO THE REPORTED ISSUE WITH THE WIRE. THERE WERE NO OTHER DEVICES OR EQUIPMENT BEING USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930508 ↗
• InjuryMay 24, 2017Material Integrity Problem; Material Integrity Problem

  THE USER FACILITY REPORTED AN ISSUE WITH THE POLYURETHANE COATING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE HYDROPHILIC COATING AT TIP OF WIRE SHEARED OFF DURING IVC FILTER REMOVAL AND LEFT IN PATIENT; THE IVC FILTER WAS REMOVED; AND THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 5/4/2017. THE BLACK POLYURETHANE COATING WAS SHEARING OFF THE DEVICE. THE COATING IS CURRENTLY IN THE PULMONARY ARTERY AND WAS DETECTED VIA FLUORO. SEE MW5069028 RECEIVED BY TERUMO ON MAY 1, 2017. "HYDROPHILLIC COATING AT TIP OF WIRE SHEARED OFF DURING IVC FILTER REMOVAL AND LEFT IN PATIENT."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6589582 ↗
• MalfunctionApr 10, 2017Peeled/Delaminated

  HYDROPHILLIC COATING AT TIP OF WIRE SHEARED OFF DURING IVC FILTER REMOVAL AND LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6485417 ↗
• MalfunctionDec 1, 2016Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE COATING OF THE DEVICE STARTED TO COME OFF THE WIRE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE GLIDEWIRE BECAME STUCK INSIDE OF A .035 SEEKER; DURING REMOVAL THE WIRE COATING STARTED TO COME UP OFF THE WIRE; IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS GOOD; AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6138115 ↗
• InjuryOct 25, 2016Break; Break

  THE USER FACILITY REPORTED GUIDEWIRE BREAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A .035 STIFF ANGLE GW BROKE OFF AT THE DISTAL END IN THE PATIENT; THE WIRE WAS REMOVED AND THE DISTAL BROKEN PORTION WAS SNARED AND REMOVED FROM THE PATIENT; THE DOCTOR WAS PERFORMING A RIGHT ILIAC ARTERY INTERVENTION FROM THE ARM; THE DOCTOR WAS POKING AT A CALCIFIED LESION IN THE ILIAC WITH THE GS3508 THROUGH A FRONT RUNNER CATHETER WHEN THE BREAKAGE OCCURRED; THE DOCTOR STATED THAT THE WIRE WAS PRETTY BEAT UP BUT DIDN'T EXPECT IT TO BREAK; THE PROCEDURE WAS UNSUCCESSFUL; AND THERE WAS NO EFFECTS ON THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6055200 ↗