GLIDEWIRE GR3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04987350773210), received between Dec 9, 2016 and Sep 29, 2026 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 19 most recent of 19 reports, 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 ↗
• 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 ↗
• InjuryDec 6, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE WIRE BROKE OFF IN THE PATIENT. THE DEVICE WAS IMPLANTED IN PATIENT AND THEN REMOVED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. A SNARE WAS USED TO REMOVE THE BROKEN WIRE. ANOTHER GS3509 WAS USED AND THE PATIENT WAS FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 16NOV2023: THE PROCEDURE PERFORMED WAS FEMORAL TIBIAL BYPASS. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18274834 ↗
• InjuryNov 30, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE 0.035 WIRE BROKE OFF. THE DEVICE WAS REMOVED AND CONFIRMED THAT IT WAS NOT INSIDE THE PATIENT UNDER FLOURO. THE ACCOUNT COULD NOT IDENTIFY A REASON WHY THE TIP BROKE OFF. THEY HAD CONNECTED THE SYRINGE TO THE CATHETER AND PULLED BACK TO GATHER BLOOD/FLUID AND THAT IS WHEN THEY NOTICED THAT THERE WAS A PIECE OF THE WIRE THAT HAD BEEN INSIDE OF THE CATHETHER OR INSIDE THE PATIENT. THE PATIENT IS STABLE AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 10 MAR 2023: THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242496 ↗
• MalfunctionJul 2, 2023Material Frayed; Material Frayed

  THE USER FACILITY REPORTED THAT THE INVOLVED 260 STIFF GLIDE DEVICE FRAYED DURING A PERIPHERAL PROCEDURE. THE PROXIMAL END OF THE WIRE FRAYED, WHICH WAS OUTSIDE THE PATIENT AND NOT IN THE SHEATH OR CATHETER. PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 19 JUB 2023: IT STARTED TO PEEL DURING THE CASE. IT WAS NOT SPECIFIED IF IT WAS CAUSED BY A TORQUE OR ANY OTHER OBJECT, BUT THE PEELING WAS CAUSED DURING MANIPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244603 ↗
• InjuryApr 27, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 16NOV2023: THE PROCEDURE PERFORMED WAS FEMORAL TIBIAL BYPASS. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16821080 ↗
• InjuryApr 5, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE 0.035 WIRE BROKE OFF. THE DEVICE WAS REMOVED AND CONFIRMED THAT IT WAS NOT INSIDE THE PATIENT UNDER FLOURO. THE ACCOUNT COULD NOT IDENTIFY A REASON WHY THE TIP BROKE OFF. THEY HAD CONNECTED THE SYRINGE TO THE CATHETER AND PULLED BACK TO GATHER BLOOD/FLUID AND THAT IS WHEN THEY NOTICED THAT THERE WAS A PIECE OF THE WIRE THAT HAD BEEN INSIDE OF THE CATHETHER OR INSIDE THE PATIENT. THE PATIENT IS STABLE AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 10 MAR 2023: THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683799 ↗
• MalfunctionNov 14, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE INVOLVED GUIDEWIRE COATING CAME OFF, USED IN A RADIAL LUE FISTULOGRAM. PATIENT WAS IN STABLE CONDITION. PROCEDURE OUTCOME WAS SUCCESSFUL. MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 27 OCT 2022: IT WAS REPORTED THAT A DIFFERENT WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO RESIDUE LEFT IN THE BODY. NO ANTI-CANCER OR INFECTIOUS AGENTS ON THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794914 ↗
• InjuryMar 26, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GW HAD COATING OR JACKET COME OFF OF THE PRODUCT DURING A PROCEDURE. THE PATIENT WAS OK, AND THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18MAR2021. THE TYPE OF PROCEDURE BEING PERFORMED WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO COATING/JACKET LEFT IN THE PATIENT'S BODY. THE PRODUCT WAS USED FOR THE ENTIRE CASE. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573896 ↗
• InjuryMar 26, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GW HAD COATING OR JACKET COME OFF OF THE PRODUCT DURING A PROCEDURE. THE PATIENT WAS OK, AND THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18MAR2021. THE TYPE OF PROCEDURE BEING PERFORMED WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO COATING/JACKET LEFT IN THE PATIENT'S BODY. THE PRODUCT WAS USED FOR THE ENTIRE CASE. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573895 ↗
• InjuryAug 27, 2020Material Separation; Material Separation

  ON 10SEP2020 TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5095860. THE EVENT DESCRIPTION STATES: "DURING REMOVAL OF AN INFERIOR VENA CAVA FILTER A TINY FRAGMENT OF THE GUI DEWIRE WAS SHEARED FROM THE WIRE. THE FRAGMENT REMAINS EMBEDDED IN THE PATIENT (RISK OF REMOVAL OUTWEIGHS BENEFIT). INFERIOR VENA CAVA FILTER WAS NOTED TO BE FRACTURED WITH A PIECE OF THE RIGHT LATERAL FILTER LEG EMBEDDED IN THE SOFT TISSUE SURROUNDING THE INFERIOR VENA CAVA- THIS WAS FOUND DURING A PROCEDURE TO REMOVE THE FILTER THE PIECE WAS LEFT EMBEDDED WITHIN THE PATIENT (RISK OF REMOVAL OUTWEIGHS BENEFIT)."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10458708 ↗
• InjuryAug 27, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THE INVOLVED GLIDE WIRE 035 260 ANGLED FRACTURED WHILE REMOVING. A VOLUNTARY MEDWATCH WAS PROVIDED BY (B)(4) HOSPITAL ON (B)(6) 2020. THE EVENT DESCRIPTION STATES: "DURING REMOVAL OF AN INFERIOR VENA CAVA FILTER A TINY FRAGMENT OF THE GUIDEWIRE WAS SHEARED FROM THE WIRE." ADDITIONAL INFORMATION WAS RECEIVED ON 31JUL2020. THE DEVICE FRACTURED INSIDE THE PATIENT; A VERY SMALL PIECE SHEARED OFF INSIDE THE PATIENT. THE PIECE WAS VERY TINY, SO THE DECISION WAS MADE TO NOT REMOVE IT FROM THE PATIENT. THE PATIENT WILL FOLLOW UP IN ONE YEAR FOR EVALUATION. THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10458707 ↗
• InjuryAug 26, 2020Material Separation; Material Separation

  ON 10SEP2020 TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT #(B)(4). THE EVENT DESCRIPTION STATES: "TRANS-JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WAS PERFORMED, AND PATIENT TOLERATED PROCEDURE WITHOUT DIFFICULTY. THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION AS HAD ORIGINALLY BEEN PLANNED. UPON COMPLETION OF THE PROCEDURE A POST PROCEDURE RADIOGRAPH WAS PERFORMED. REVIEW OF THE RADIOGRAPH REVEALED A RADIOPAQUE FOREIGN BODY PROJECTING OVER THE LIVER. SUBSEQUENT KIDNEY, URETER, AND BLADDER, AND CT WAS OBTAINED, REVEALING A FOREIGN BODY IN ONE OF THE PERIPHERAL VEINS OF THE LIVER. RETROSPECTIVE REVIEW OF ALL THE IMAGING IN THE CASE REVEALED THE LINEAR OPACITY WAS NOTED TO APPEAR AFTER PORTAL VENOUS ACCESS WAS OBTAINED. ACCESS WAS OBTAINED AND A 0.035-INCH GLIDEWIRE WAS USED TO NAVIGATE INTO THE PORTAL VEIN WHILE USING A RING TIPS SET. AS A RESULT, THIS IS LIKELY TO REFLECT THE SHEARED HYDROPHILIC COATING OF A GLIDEWIRE AS IT PROBABLY SHEARED ALONG THE CANNULA. AFTER REVIEWING THE CT, THE PATIENT WAS TOLD THAT GIVEN THE LOCATION IT IS NOT LIKELY TO CAUSE HARM. IN ADDITION, ATTEMPTING RETRIEVAL OF SUCH A DEVICE AT THIS TIME OR IN THE FUTURE WOULD LIKELY C

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10454500 ↗
• InjuryAug 26, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED GUIDEWIRE WAS USED DURING THE PROCEDURE. THE HYDROPHILIC COATING CAME OFF THE WIRE AND WAS LEFT BEHIND IN THE PATIENT. IT WAS NOT KNOWN UNTIL AFTER THE FACT. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT. THE PROCEDURE OUTCOME WAS REPORTED TO BE DONE. THE PATIENT'S CONDITION WAS GOOD. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 10AUG2020. THEY BELIEVE IT WAS THE POLYURETHANE COATING THAT WAS LEFT BEHIND. IT WAS A TIPS PROCEDURE AND THE CASE TURNED OUT GOOD AND THEY ARE NOT CONCERNED ABOUT WHAT WAS LEFT BEHIND. THEY DID NOT REALIZE WHAT WAS LEFT BEHIND UNTIL AFTER; HOWEVER, WHERE IT WAS LEFT THE TRACTS WAS CLOSED UP FOR THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11AUG2020. FROM WHAT THEY GATHERED IT WAS THE "COATING" OR PLASTIC JACKET. THEY STATED THAT THE CASE WAS COMPLETED. THEY WERE USING THE COOK TIPS KIT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10454498 ↗
• MalfunctionNov 30, 2018Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE CUSTOMER CALLED AND SAID PART OF THE WIRE BROKE OFF WHILE PULLING OUT OF PATIENT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. THE PATIENT WAS REPORTED TO BE IN STABLE IN CONDITION. THE PROCEDURE OUTCOME WAS REPORTED TO BE GOOD. NO PATIENT INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 11/20/18. THE PROCEDURE BEING PERFORMED WAS A POST PERIPHERAL ANGIOGRAM. THE WIRE DID NOT BREAK, AND IT WAS THE COATING. AN X-RAY MATCHED THE FRAGMENT WITH WIRE. THE WIRE WAS REMOVED FROM THE PATIENT THROUGH THE CATHETER. THERE WERE NO OTHER DEVICES OR EQUIPMENT BEING USED WITH THE REPORTED PRODUCT SUCH AS METAL DEVICES OR METAL ENTRY NEEDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8120722 ↗
• InjuryOct 11, 2018Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5078309 ON SEPTEMBER 26, 2018. THE EVENT DESCRIPTION STATES THE FOLLOWING: WHILE ATTEMPTING TO REMOVE AN IVC FILTER, THE GUIDEWIRE BROKE AND IT WAS SUCCESSFULLY REMOVED.

  Patient problems: No Code Available

  MAUDE report 7955946 ↗
• InjuryDec 9, 2016Material Separation; Material Separation

  THE USER FACILITY REPORTED GUIDEWIRE BREAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE GLIDEWIRE BROKE DURING AN AORTOGRAM; THE TIP CAME APART FROM THE MAIN BODY OF THE WIRE; AND THE PATIENT WAS REPORTED IN GOOD CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6157858 ↗