GLIDEWIRE GR3506Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04987350773159), received between Mar 21, 2017 and Nov 17, 2025 — classified as 12 injuries, 4 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• 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 ↗
• 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 ↗
• InjurySep 11, 2025Device Dislodged or Dislocated; Migration; 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 23034720 ↗
• InjuryMay 23, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE BROKE OFF INSIDE OF THE PATIENT. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 30APR2025: PATIENT UNDERWENT A DIAGNOSTIC ATRIOVENTRICULAR (AV) FISTULA WITH ATTEMPTED RECANALIZATION OF THROMBOSED CEPHALIC ARCH STENT. THEY WERE ABLE TO RETRIEVE AND SUBSEQUENTLY EXTERIORIZE FOREIGN BODY WITH A SNARE AND CATHETER. THE GUIDEWIRE THAT BROKE OFF WAS A 0.035 WIRE. THE WIRE WAS USED WITH A 5FR KUMPE CATHETER. THE PATIENT WAS STABLE AND THERE WAS NO HEMODYNAMIC ISSUES ENCOUNTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22079558 ↗
• InjuryMay 23, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE BROKE OFF INSIDE OF THE PATIENT. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 30APR2025: PATIENT UNDERWENT A DIAGNOSTIC ATRIOVENTRICULAR (AV) FISTULA WITH ATTEMPTED RECANALIZATION OF THROMBOSED CEPHALIC ARCH STENT. THEY WERE ABLE TO RETRIEVE AND SUBSEQUENTLY EXTERIORIZE FOREIGN BODY WITH A SNARE AND CATHETER. THE GUIDEWIRE THAT BROKE OFF WAS A 0.035 WIRE. THE WIRE WAS USED WITH A 5FR KUMPE CATHETER. THE PATIENT WAS STABLE AND THERE WAS NO HEMODYNAMIC ISSUES ENCOUNTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22079549 ↗
• InjuryJun 7, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT DURING A CRYO ATRIAL FIBRILLATION PROCEDURE, AN EFFUSION OCCURRED IN THE INFERIOR VENA CAVA (IVC) WHICH REQUIRED A VASCULAR BALLOON. THERE WERE DIFFICULTIES WHILE TRYING TO GAIN ACCESS INTO THE RIGHT ATRIUM AT THE BEGINNING OF THE PROCEDURE. EVENTUALLY ALL ACCESSES WERE MADE IN THE PROPER LOCATIONS. AFTER FREEZING THE LEFT VEINS AND MOVING TO THE RIGHT SIDE, THE PATIENT'S PRESSURE WAS DROPPING, AND HEART RATE WAS INCREASING. NOTHING OBSERVED WITH THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) NOR THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). AFTER CHECKING FOR EFFUSION, THE PHYSICIAN INJECTED CONTRAST LOW IN THE IVC LOOKING FOR A PERFORATION AND FOUND A SMALL ONE BELOW THE HEART JUST BELOW THE DIAPHRAGM ON THE LATERAL SIDE OF THE IVC. LIKELY THE PERFORATION WAS DUE TO ONE OF THE CATHETERS DURING ACCESS. A VASCULAR BALLOON WAS INFLATED IN IVC WITH STENT PLACED TO SEAL THE PERFORATION. THE CASE WAS ABANDONED BEFORE ANY RF WAS DONE. THE PATIENT WAS STABILIZED, AND NO FURTHER COMPLICATIONS OCCURRED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THERE WERE NO CATHETERS IN IVC. IT IS ALLEGED THAT THE GUIDEWIRE PUNCTURED THE IVC AT BEGINNING OF P

  Patient problems: Diminished Pulse Pressure; Perforation

  MAUDE report 17084249 ↗
• InjuryJul 25, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TC-WIRE DEVICE WAS USED THROUGH AN ANGIOGRAPHIC CATHETER. THE PATIENT COMPLAINED OF SHARP PAIN AND THE WIRE WAS REMOVED AND INSPECTED. UPON INSPECTION THE PHYSICIAN FOUND THAT A PORTION OF THE WIRE WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED ON 29 JUN 2022: THE PROCEDURE TAKING PLACE FOR THE PATIENT WHEN THE EVENT OCCURRED WAS A VENOGRAM PROCEDURE. THE BREAK WAS AT THE DISTAL TIP. THE FRAGMENT WAS NOT ISOLATED OR REMOVED FROM THE PATIENT. THE FRAGMENT WAS UNABLE TO BE LOCATED. THE FRAGMENT WAS APPROXIMATELY 0.5CM. THE PATIENT WAS REFERRED TO A SURGEON FOR EVALUATION. THE PATIENT IS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL AS INTENDED. THE WIRE WAS USED WITH A STRAIGHT ANGIOGRAPHIC CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 30 JUN 2022: SURGICAL INTERVENTION WAS NOT NECESSARY AT THIS TIME FOR THE PATIENT.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15094836 ↗
• InjuryJul 22, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TC-WIRE DEVICE WAS USED THROUGH AN ANGIOGRAPHIC CATHETER. THE PATIENT COMPLAINED OF SHARP PAIN AND THE WIRE WAS REMOVED AND INSPECTED. UPON INSPECTION THE PHYSICIAN FOUND THAT A PORTION OF THE WIRE WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PROCEDURE TAKING PLACE FOR THE PATIENT WHEN THE EVENT OCCURRED WAS A VENOGRAM PROCEDURE. THE BREAK WAS AT THE DISTAL TIP. THE FRAGMENT WAS NOT ISOLATED OR REMOVED FROM THE PATIENT. THE FRAGMENT WAS UNABLE TO BE LOCATED. THE FRAGMENT WAS APPROXIMATELY 0.5CM. THE PATIENT WAS REFERRED TO A SURGEON FOR EVALUATION. THE PATIENT IS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL AS INTENDED. THE WIRE WAS USED WITH A STRAIGHT ANGIOGRAPHIC CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: SURGICAL INTERVENTION WAS NOT NECESSARY AT THIS TIME FOR THE PATIENT.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15086408 ↗
• MalfunctionFeb 17, 2022Component Missing; Component Missing

  THE USER FACILITY REPORTED THAT THERE WAS NO POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE INVOLVED. THE PATIENT WAS OK. THE OUTCOME OF THE PROCEDURE WAS POSITIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 01 FEB 2022: THE PROCEDURE WAS COMPLETED USING A COOK ROADRUNNER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548370 ↗
• MalfunctionAug 5, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 20AUG2021. THE TYPE OF PROCEDURE BEING PERFORMED WAS A NON-VASCULAR. THE WIRE BROKE INSIDE THE PATIENT AND WAS RETRIEVED. ANOTHER GLIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION WAS STABLE; THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281831 ↗
• InjuryOct 18, 2019Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5089711. THE EVENT DESCRIPTION STATES: "PT PRESENTED TO IR FOR PLACEMENT OF BILATERAL NEPHROSTOMY TUBES. DURING PROCEDURE GUIDE WIRE SHEARED OFF AND WAS RETAINED IN SUBQ FAT AROUND KIDNEY. PROVIDER MADE PT AND WIFE AWARE. NO FURTHER INTERVENTIONS WERE NECESSARY".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9208553 ↗
• InjuryOct 18, 2019Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # 5089711. THE EVENT DESCRIPTION STATES: "PT PRESENTED TO IR FOR PLACEMENT OF BILATERAL NEPHROSTOMY TUBES. DURING PROCEDURE GUIDEWIRE SHEARED OFF AND WAS RETAINED IN SUBQ FAT AROUND KIDNEY. PROVIDER MADE PT AND WIFE AWARE. NO FURTHER INTERVENTIONS WERE NECESSARY".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9208549 ↗
• InjuryDec 28, 2018Break; Break

  THE USER FACILITY REPORTED THAT WHILE ATTEMPTING TO DO AN EXTERNAL ILIAC INTERVENTION THE PHYSICIAN HAD THE GLIDEWIRE UP THE LEFT SIDE WITH PLAN OF GOING TO THE RIGHT SIDE. THE DISTAL PORTION OF THE GLIDEWIRE SNAPPED OFF INSIDE OF THE PATIENT, WITH NO EXCESSIVE EXERTION ON THE WIRE. THE PHYSICIAN WAS ABLE TO USE A SNARE TO REMOVE THE BROKEN PIECE AND NO INJURY TO THE PATIENT WAS REPORTED. NO OTHER DEVICES WERE BEING USED WITH THE WIRE AT THE TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW GLIDEWIRE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Code Available

  MAUDE report 8203257 ↗
• MalfunctionNov 21, 2017Break; Failure to Advance

  DURING A PROCEDURE, THE GLIDE WIRE COATING FRACTURED, UNABLE TO ADVANCE CATHETER SO WIRE WAS REMOVED. FRACTURE NOTED TO COATING. NEW WIRE WAS USED. NO ADVERSE EFFECTS NOTED. ALL PIECES OF COATING ACCOUNTED FOR AFTER PROCEDURE. NO PT HARM NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7049126 ↗
• MalfunctionMar 21, 2017Fracture; Fracture

  THE USER FACILITY REPORTED SHEARING OF THE WIRE DURING A DX CATH PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER DIAGNOSTIC ANGIOGRAPHY THE WIRE WAS REMOVED FROM THE BODY; THE WIRE WAS NOTED TO BE SHEARED AND CLOSE TO BREAKING OFF ABOUT 10 CM FROM THE DISTAL (ANGLED) END; THE PROCEDURE WAS COMPLETED; AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED, PATIENT IS DOING OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6421552 ↗