GLIDEWIRE GS3510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350773678), received between Jan 7, 2022 and Feb 3, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THEY WERE UNABLE TO BACKLOAD A CATHETER ONTO THE WIRE. WHEN TRYING TO BACKLOAD THE CATHETER ON TO THE WIRE, THE HYDROPHILIC MATERIAL AT THE BACK OF THE WIRE WOULD BUNCH UP AND PREVENT THE CATHETER FROM BEING ADVANCED. THE WIRE WAS REMOVED AND A NEW GLIDEWIRE WAS INSERTED. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. NO BLOOD LOSS. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09JAN2025: THE PROCEDURE PERFORMED WAS AN AORTAGRAM WITH RUNOFF OF LOWER LEG. THERE WAS NO IMPACT TO THE PATIENT FROM THE HYDROPHILIC MATERIAL BUNCHING UP. THE WIRE WAS EXPOSED WHEN THE HYDROPHILIC MATERIAL BUNCHED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293987 ↗
• InjuryFeb 3, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THEY WERE UNABLE TO BACKLOAD A CATHETER ONTO THE WIRE. WHEN TRYING TO BACKLOAD THE CATHETER ON TO THE WIRE, THE HYDROPHILIC MATERIAL AT THE BACK OF THE WIRE WOULD BUNCH UP AND PREVENT THE CATHETER FROM BEING ADVANCED. THE WIRE WAS REMOVED AND A NEW GLIDEWIRE WAS INSERTED. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. NO BLOOD LOSS. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09JAN2025: THE PROCEDURE PERFORMED WAS AN AORTAGRAM WITH RUNOFF OF LOWER LEG. THERE WAS NO IMPACT TO THE PATIENT FROM THE HYDROPHILIC MATERIAL BUNCHING UP. THE WIRE WAS EXPOSED WHEN THE HYDROPHILIC MATERIAL BUNCHED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293331 ↗
• MalfunctionNov 7, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL INTERVENTION USING A 6FR SHEATH IN THE RIGHT COMMON FEMORAL ARTERY (CFA), IT WAS OBSERVED THAT THE WIRE BEGAN TO DELAMINATE AFTER INITIAL ACCESS. THE WIRE WAS SUBSEQUENTLY REMOVED FROM THE SHEATH. ADDITIONAL INFORMATION RECEIVED ON 09 OCT 2024: IT WAS CONFIRMED THAT NO WIRE FRAGMENTS WERE LEFT IN THE PATIENT, AND THE PATIENT REMAINED STABLE. A NEW STIFF WIRE WAS USED TO REPLACE THE DEFECTIVE ONE, ALLOWING THE PROCEDURE TO CONTINUE SUCCESSFULLY. THE SAMPLE WAS CONTAMINATED BY BLOOD AND BODY FLUID BUT WAS NOT CONTAMINATED BY INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627135 ↗
• InjuryJan 7, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE SEVERED IN HALF AS THE DOCTOR WAS SPINNING THE WIRE THRU A TIGHT LESION. HE WAS ABLE TO SNARE THE WIRE WITHOUT CAUSING HARM TO THE PATIENT. THE PATIENT WAS STABLE. THE PROCEDURE WAS SUCCESSFUL, HOWEVER WAS A PROLONGED CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 16DECEMBER 2021: THE PROCEDURE WAS AN AORTOGRAM, PELVIC ANGIOGRAM, AND LEFT SUPERFICIAL FEMORAL ARTERY (L SFA) WITH LITHOTRIPSY AND SELF-EXPANDING STENT PLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 17DECEMBER 2021: NO FRAGMENT WAS LEFT IN THE PATIENT. THE DOCTOR ONLY HAD TO SNARE THE WIRE TO REMOVE IT. IT IS UNKNOWN IF THERE WAS ANY OTHER EQUIPMENT OR DEVICES USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196512 ↗
• InjuryJan 7, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE SEVERED IN HALF AS THE DOCTOR WAS SPINNING THE WIRE THRU A TIGHT LESION. HE WAS ABLE TO SNARE THE WIRE WITHOUT CAUSING HARM TO THE PATIENT. THE PATIENT WAS STABLE. THE PROCEDURE WAS SUCCESSFUL, HOWEVER WAS A PROLONGED CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 16DECEMBER 2021: THE PROCEDURE WAS AN AORTOGRAM, PELVIC ANGIOGRAM, AND LEFT SUPERFICIAL FEMORAL ARTERY (L SFA) WITH LITHOTRIPSY AND SELF-EXPANDING STENT PLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 17DECEMBER 2021: NO FRAGMENT WAS LEFT IN THE PATIENT. THE DOCTOR ONLY HAD TO SNARE THE WIRE TO REMOVE IT. IT IS UNKNOWN IF THERE WAS ANY OTHER EQUIPMENT OR DEVICES USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196485 ↗