GLIDEWIRERecalls & reported problems across all models

We found 30 models of GLIDEWIRE by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 194 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2016 and Sep 29, 2026 — classified as 135 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Material Separation” (87 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 problems

GLIDEWIRE models

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

• GLIDEWIRE GS3509

  WIRE, GUIDE, CATHETER
  55 reports
• GLIDEWIRE GR3508

  WIRE, GUIDE, CATHETER
  22 reports
• GLIDEWIRE GS3508

  WIRE, GUIDE, CATHETER
  20 reports
• GLIDEWIRE GR3509

  WIRE, GUIDE, CATHETER
  19 reports
• GLIDEWIRE GR3506

  Laparoscope, general & plastic surgery
  16 reports
• GLIDEWIRE GS3506

  WIRE, GUIDE, CATHETER
  8 reports
• GLIDEWIRE GR3513

  WIRE, GUIDE, CATHETER
  8 reports
• GLIDEWIRE UWS1035

  Laparoscope, general & plastic surgery
  5 reports
• GLIDEWIRE GS3510

  Laparoscope, general & plastic surgery
  5 reports
• GLIDEWIRE GR3806

  WIRE, GUIDE, CATHETER
  4 reports
• GLIDEWIRE UWR1035

  CATHETER, UROLOGICAL
  3 reports
• GLIDEWIRE GR1805

  WIRE, GUIDE, CATHETER
  3 reports
• GLIDEWIRE GR3525

  WIRE, GUIDE, CATHETER
  2 reports
• GLIDEWIRE GR3535

  Wire, guide, catheter
  2 reports
• GLIDEWIRE GS3543

  Wire, guide, catheter
  2 reports
• GLIDEWIRE RG*GA1818SP

  Wire, guide, catheter
  2 reports
• GLIDEWIRE EWR6025

  Endoscopic guidewire, gastroenterology-urology
  2 reports
• GLIDEWIRE UWS1038

  Laparoscope, general & plastic surgery
  2 reports
• GLIDEWIRE GR3507

  WIRE, GUIDE, CATHETER
  2 reports
• GLIDEWIRE GS3505

  WIRE, GUIDE, CATHETER
  2 reports
• GLIDEWIRE RG*GW1618SP

  Wire, guide, catheter
  1 report
• GLIDEWIRE RG*ES1818SP

  Wire, guide, catheter
  1 report
• GLIDEWIRE RG*GW1818SP

  Wire, guide, catheter
  1 report
• GLIDEWIRE UWR6035

  WIRE, GUIDE, CATHETER
  1 report
• GLIDEWIRE UWR1025

  WIRE, GUIDE, CATHETER
  1 report
• GLIDEWIRE UWS5038

  WIRE, GUIDE, CATHETER
  1 report
• GLIDEWIRE GR3501

  WIRE, GUIDE, CATHETER
  1 report
• GLIDEWIRE GR3503

  Laparoscope, general & plastic surgery
  1 report
• GLIDEWIRE GS3504

  Laparoscope, general & plastic surgery
  1 report
• GLIDEWIRE GS3805

  Laparoscope, general & plastic surgery
  1 report

Recent GLIDEWIRE adverse event reports

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

• InjurySep 29, 2026Break

  Terumo received the following information: It was reported that during a femoral angiogram procedure, the physician noted that a portion of the Glidewire fractured. The broken wire fragment remained in the patient.Additional information received 15-Sept-2026: The physician attempted to remove the fragment but was unsuccessful. The fragment did not migrate, and the physician opted to leave it in place. No patient injury was reported. The estimated blood loss during the procedure was 400 mL. The patient had above knee amputation related to poor outflow of bypass graft/intractable pain/non-ambulatory status on (b)(6) 2026.

  Patient problems: Foreign Body In Patient

  MAUDE report 50934451 ↗
• InjurySep 29, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50934450 ↗
• MalfunctionSep 8, 2026Unraveled Material; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678678 ↗
• InjurySep 3, 2026Break; Difficult to Remove; Material Separation; Physical Resistance/Sticking

  Terumo received the following information: It was reported that A 72-year-old male was undergoing a cardiac device implantation procedure when a 0.018-inch guidewire became trapped beneath the left clavicle and could not be removed through the sheath. A CT scan indicated the wire was located superficially in the subcutaneous tissue. The patient was brought back to the electrophysiology lab, prepped and draped in standard fashion. Fluoroscopy was used to mark the location of the wire. This wire was not attached to anything in the heart and was essentially entrapped behind the clavicle, likely in the fascia. An incision was made over the sternoclavicular joint, and the dissection was carried down into the subcutaneous tissue over the head of the clavicle. Without entering the left pleural space, we followed the clavicle and located the wire. lt was grasped with the hemostat and retrieved without difficulty. We then irrigated, making sure there was no bleeding. Satisfied, the wound was closed in a layered fashion with absorbable suture. The patient tolerated the procedure well. There were no unforeseen complications. During advancement of the glidewire through the patient's left subcl

  Patient problems: Foreign Body In Patient

  MAUDE report 50590719 ↗
• InjuryFeb 10, 2026Peeled/Delaminated

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5180837. THE EVENT DESCRIPTION STATES: "DURING AN ATTEMPTED PORT-A-CATH PLACEMENT, THE COATING ON THE GLIDEWIRE SHEARED WITH A FRAGMENT OF THE COATING REMAINING IN THE PATIENT'S SUBCUTANEOUS TISSUE." ADDITIONAL INFORMATION WAS RECEIVED ON 14 JAN 2026: USER ERROR MAY BE TO BLAME AS THE GUIDEWIRE WAS THREADED THROUGH A NEEDLE. THE SHEARED FRAGMENT IS NOT CAUSING ANY ISSUES AND HAS NOT MIGRATED AS IT IS IN THE SUBCUTANEOUS TISSUE. THE ESTIMATED BLOOD LOSS WAS 5ML. THE PATIENT WAS FINE. THERE WAS NO ISSUE WITH HEMOSTASIS. ONLY A PORT-A-CATH KIT WAS USED WITH THE GLIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24308708 ↗
• InjuryFeb 10, 2026Peeled/Delaminated

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5180837. THE EVENT DESCRIPTION STATES: "DURING AN ATTEMPTED PORT-A-CATH PLACEMENT, THE COATING ON THE GLIDEWIRE SHEARED WITH A FRAGMENT OF THE COATING REMAINING IN THE PATIENT'S SUBCUTANEOUS TISSUE." ADDITIONAL INFORMATION WAS RECEIVED ON 14 JAN 2026: USER ERROR MAY BE TO BLAME AS THE GUIDEWIRE WAS THREADED THROUGH A NEEDLE. THE SHEARED FRAGMENT IS NOT CAUSING ANY ISSUES AND HAS NOT MIGRATED AS IT IS IN THE SUBCUTANEOUS TISSUE. THE ESTIMATED BLOOD LOSS WAS 5ML. THE PATIENT WAS FINE. THERE WAS NO ISSUE WITH HEMOSTASIS. ONLY A PORT-A-CATH KIT WAS USED WITH THE GLIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24308707 ↗
• InjuryJan 29, 2026Material Separation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GLIDEWIRE TIP FRACTURED ON PLAQUE INSIDE THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). THE ENTIRE WIRE WAS SUCCESSFULLY REMOVED. THERE WAS NO BLOOD LOSS, AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 12JAN2026: THE PROCEDURE PERFORMED WAS A PERIPHERAL REVASC OF THE SFA. THE WIRE WAS REMOVED, AND A SNARE WAS USED TO PULL THE TIP OUT. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE TIP WAS REMOVED ENTIRELY. THE PATIENT WAS STABLE FOLLOWING THE REMOVAL OF THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24212171 ↗
• InjuryJan 29, 2026Material Separation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GLIDEWIRE TIP FRACTURED ON PLAQUE INSIDE THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). THE ENTIRE WIRE WAS SUCCESSFULLY REMOVED. THERE WAS NO BLOOD LOSS, AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 12JAN2026: THE PROCEDURE PERFORMED WAS A PERIPHERAL REVASC OF THE SFA. THE WIRE WAS REMOVED, AND A SNARE WAS USED TO PULL THE TIP OUT. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE TIP WAS REMOVED ENTIRELY. THE PATIENT WAS STABLE FOLLOWING THE REMOVAL OF THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24212170 ↗
• 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 ↗
• InjuryNov 17, 2025Difficult to Insert; Peeled/Delaminated; Loosening of Implant Not Related to Bone-Ingrowth; Difficult to Insert; Peeled/Delaminated; Loosening of Implant Not Related to Bone-Ingrowth

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE PROCEDURE PERFORMED WAS A PACEMAKER IMPLANT. THE VASCULAR SURGEON OBTAINED ACCESS INTO VEIN VIA NEEDLE; HOWEVER, WAS UNABLE TO ADVANCE THE STARTER WIRE. THE SURGEON SWITCHED TO A GLIDEWIRE AND WAS ABLE TO ADVANCE WITH SOME REPOSITIONING. THE PROCEDURE CONTINUED AND LEADS WERE POSITIONED. NO SINE WAS DONE UNTIL END OF CASE. ARTIFACT WAS NOTED ON THE SCREEN. UPON INSPECTION BY INTERVENTIONAL CARDIOLOGIST, IT WAS NOTICED THAT THE DISTAL END OF THE GLIDEWIRE HAD SOME TYPE OF DEFORMATION. IT WAS BELIEVED THAT DURING REPOSITIONING OF THE GLIDEWIRE THROUGH THE NEEDLE DAMAGE MAY HAVE OCCURRED. THE WIRE WAS DISCARDED AND THE PATIENT WAS SENT TO HAVE COMPUTERIZED TOMOGRAPHY (CT) AND THEN TO INTERVENTIONAL RADIOLOGY (IR) TO TRY AND SNARE THE PIECE OF WIRE. HOWEVER, THE LOCATION OF THE PIECE OF WIRE AND PACEMAKER LEADS MADE IT UNSAFE TO TRY. IR BELIEVED THE PIECE OF WIRE WAS IN A SAFE PLACE WITHIN THE PULMONARY VEIN AND WILL REENDOTHELIALIZE. ADDITIONAL INFORMATION WAS RECEIVED ON 29OCT2025: THE OBJECT MEASURES ROUGHLY 10CM IN LENGTH, AS MEASURED ON IMAGING BY THE PHYSICIAN, WHICH WAS CONSISTENT WITH THE LENGTH OF THE DISTAL GLI

  Patient problems: Foreign Body In Patient

  MAUDE report 23573671 ↗
• InjuryNov 17, 2025Difficult to Insert; Peeled/Delaminated; Migration; Difficult to Insert; Peeled/Delaminated; Migration

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE PROCEDURE PERFORMED WAS A PACEMAKER IMPLANT. THE VASCULAR SURGEON OBTAINED ACCESS INTO VEIN VIA NEEDLE; HOWEVER, WAS UNABLE TO ADVANCE THE STARTER WIRE. THE SURGEON SWITCHED TO A GLIDEWIRE AND WAS ABLE TO ADVANCE WITH SOME REPOSITIONING. THE PROCEDURE CONTINUED AND LEADS WERE POSITIONED. NO SINE WAS DONE UNTIL END OF CASE. ARTIFACT WAS NOTED ON THE SCREEN. UPON INSPECTION BY INTERVENTIONAL CARDIOLOGIST, IT WAS NOTICED THAT THE DISTAL END OF THE GLIDEWIRE HAD SOME TYPE OF DEFORMATION. IT WAS BELIEVED THAT DURING REPOSITIONING OF THE GLIDEWIRE THROUGH THE NEEDLE DAMAGE MAY HAVE OCCURRED. THE WIRE WAS DISCARDED AND THE PATIENT WAS SENT TO HAVE COMPUTERIZED TOMOGRAPHY (CT) AND THEN TO INTERVENTIONAL RADIOLOGY (IR) TO TRY AND SNARE THE PIECE OF WIRE. HOWEVER, THE LOCATION OF THE PIECE OF WIRE AND PACEMAKER LEADS MADE IT UNSAFE TO TRY. IR BELIEVED THE PIECE OF WIRE WAS IN A SAFE PLACE WITHIN THE PULMONARY VEIN AND WILL REENDOTHELIALIZE. ADDITIONAL INFORMATION WAS RECEIVED ON 29OCT2025: THE OBJECT MEASURES ROUGHLY 10CM IN LENGTH, AS MEASURED ON IMAGING BY THE PHYSICIAN, WHICH WAS CONSISTENT WITH THE LENGTH OF THE DISTAL GLI

  Patient problems: Foreign Body In Patient

  MAUDE report 23573642 ↗
• InjuryOct 28, 2025Break; Break

  TERUMO MEDICAL RECEIVED TWO FDA MEDWATCH REPORTS # MW5175308. 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 JULY 11. 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 23408968 ↗
• InjuryOct 28, 2025Break; Break

  TERUMO MEDICAL RECEIVED TWO FDA MEDWATCH REPORTS # MW5175308. 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 JULY 11. 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 23408950 ↗
• InjurySep 11, 2025Material Fragmentation; Device Dislodged or Dislocated; Migration; Material Fragmentation; Device Dislodged or Dislocated; Migration

  TERUMO MEDICAL RECEIVED REPORTED INFORMATION INDICATING THAT DURING A CEREBRAL ANGIOGRAM PROCEDURE, THE DISTAL TIP OF A RADIFOCUS TC-WIRE V GUIDEWIRE SHEARED OFF AND COULD NOT BE RETRIEVED DUE TO ITS LOCATION. THE PROCEDURE WAS PERFORMED TO ADDRESS RIGHT CERVICAL INTERNAL CAROTID ARTERY (ICA) STENOSIS, BASILAR STENOSIS, AND BILATERAL INTRACRANIAL ATHEROSCLEROTIC DISEASE. THE GUIDEWIRE WAS PASSED THROUGH A MERIT MARQUIS STOPCOCK. A NEW GUIDEWIRE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. A NEUROLOGICAL EVALUATION WAS PERFORMED POST-PROCEDURE, AND THE PATIENT WAS REPORTED TO BE NEUROLOGICALLY INTACT. MINIMAL BLOOD LOSS WAS REPORTED. THE PROCEDURE PERFORMED WAS A CEREBRAL ANGIOGRAM. THE PATIENT HAD A MEDICAL HISTORY THAT INCLUDED FACTOR V LEIDEN, HYPERTENSION (HTN), DIABETES MELLITUS (DM), AND WAS TAKING DAILY ASPIRIN AT A DOSE OF 325 MILLIGRAMS (MG). THE PATIENT PRESENTED WITH ACUTE RIGHT LEG WEAKNESS AND RIGHT FACIAL DROOP AND RECEIVED TENECTEPLASE (TNK), WHICH RESULTED IN SYMPTOM IMPROVEMENT. RELEVANT IMAGING INCLUDED COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA), WHICH DEMONSTRATED RIGHT CERVICAL INTERNAL CAROTID ARTERY (ICA) STENOSIS, BASILAR STENOSIS, AND BILATE

  Patient problems: Foreign Body In Patient; Ischemia Stroke

  MAUDE report 23034721 ↗

Other Terumo Corporation products

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• RUNTHROUGH7 models · 170 reports
• CAPIOXRX9 models · 162 reports
• GLIDEWIRE ADVANTAGE5 models · 79 reports
• GLIDECATH9 models · 57 reports
• R2P MISAGO13 models · 54 reports
• NAVICROSS11 models · 49 reports
• GUIDE WIRE M6 models · 37 reports