GLIDEWIRE GR3806Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04987350773357), received between Aug 2, 2019 and Aug 3, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Separation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR INSERTED THE GLIDEWIRE THROUGH HIS ACCESS NEEDLE AND IT SHEARED OFF ABOUT 30-40CM OF THE JACKET OF THE WIRE. THE DOCTOR HAD TO ACCESS THE OPPOSITE FEMORAL ARTERY TO RETRIEVE THE DETACHED SLEEVE WITH A SNARE. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 23JUL2020. AN ANGIO PROCEDURE WAS BEING PERFORMED. THEY ARE NOT AWARE THAT ANY OF THE GLIDEWIRE WAS LEFT IN THE PATIENT. FLUOROSCOPY WAS USED TO SNARE THE JACKET. THERE WAS NO HARM TO THE PATIENT. ONCE JACKET PORTION WAS SNARED, THEY FINISHED GETTING THEIR IMAGING.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10355831 ↗
• InjuryAug 3, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR INSERTED THE GLIDEWIRE THROUGH HIS ACCESS NEEDLE AND IT SHEARED OFF ABOUT 30-40CM OF THE JACKET OF THE WIRE. THE DOCTOR HAD TO ACCESS THE OPPOSITE FEMORAL ARTERY TO RETRIEVE THE DETACHED SLEEVE WITH A SNARE. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 23JUL2020. AN ANGIO PROCEDURE WAS BEING PERFORMED. THEY ARE NOT AWARE THAT ANY OF THE GLIDEWIRE WAS LEFT IN THE PATIENT. FLUOROSCOPY WAS USED TO SNARE THE JACKET. THERE WAS NO HARM TO THE PATIENT. ONCE JACKET PORTION WAS SNARED, THEY FINISHED GETTING THEIR IMAGING.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10355829 ↗
• InjuryAug 2, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A PERCUTANEOUS NEPHROLITHOTOMY FOR A VERY EXTENSIVE CAST STONE IN THE RIGHT KIDNEY, THERE WAS A GREAT DEAL OF DIFFICULTY IN GETTING GUIDEWIRE ACCESS PAST THE STONES INTO THE URETER (CASE PREVIOUSLY FAILED), HE HAD ACCESS WITH AN 18GA X 15CM COOK TROCAR NEEDLE AND EVENTUALLY ATTEMPTED TO CROSS USING A GR3806 GLIDEWIRE. HE WAS UNABLE TO GET THE WIRE THROUGH THE CALYX TO THE URETER, CONTRAST WAS INJECTED TO HELP WITH NAVIGATION, UPON REMOVING THE WIRE IT WAS NOTICED THAT THE POLYURETHANE JACKET WAS SHEARED OFF LEAVING JUST THE NITINOL CORE WIRE FOR ABOUT THE DISTAL 5CM. HE ATTEMPTED ACCESS WITH ANOTHER GR3806 WIRE AND THIS TIME WAS ABLE TO GET DOWN THE URETER; HOWEVER, WAS UNABLE TO PASS A 4FR KUMPE CATHETER OR DILATOR TO BE ABLE TO INSERT THE SCOPE TO RETRIEVE THE JACKET FRAGMENT AND PERFORM THE LITHOTOMY. THE CASE WAS EVENTUALLY ABORTED WITH THE APPROXIMATELY 5CM PORTION OF THE JACKET STILL IN THE PATIENT. THE DOCTOR AGREED THAT IT WAS VERY LIKELY THE JACKET OF THE WIRE WAS SHEARED OFF AGAINST THE BLUNT METAL CANNULA OF THE COOK TROCAR NEEDLE DUE TO PERHAPS BECOMING ENTRAPPED AGAINST A STONE OR POSSIBLY STICKY FROM THE CONTRAST. T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8855836 ↗
• InjuryAug 2, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A PERCUTANEOUS NEPHROLITHOTOMY FOR A VERY EXTENSIVE CAST STONE IN THE RIGHT KIDNEY, THERE WAS A GREAT DEAL OF DIFFICULTY IN GETTING GUIDEWIRE ACCESS PAST THE STONES INTO THE URETER (CASE PREVIOUSLY FAILED), HE HAD ACCESS WITH AN 18GA X 15CM COOK TROCAR NEEDLE AND EVENTUALLY ATTEMPTED TO CROSS USING A GR3806 GLIDEWIRE. HE WAS UNABLE TO GET THE WIRE THROUGH THE CALYX TO THE URETER, CONTRAST WAS INJECTED TO HELP WITH NAVIGATION, UPON REMOVING THE WIRE IT WAS NOTICED THAT THE POLYURETHANE JACKET WAS SHEARED OFF LEAVING JUST THE NITINOL CORE WIRE FOR ABOUT THE DISTAL 5CM. HE ATTEMPTED ACCESS WITH ANOTHER GR3806 WIRE AND THIS TIME WAS ABLE TO GET DOWN THE URETER; HOWEVER, WAS UNABLE TO PASS A 4FR KUMPE CATHETER OR DILATOR TO BE ABLE TO INSERT THE SCOPE TO RETRIEVE THE JACKET FRAGMENT AND PERFORM THE LITHOTOMY. THE CASE WAS EVENTUALLY ABORTED WITH THE APPROXIMATELY 5CM PORTION OF THE JACKET STILL IN THE PATIENT. THE DOCTOR AGREED THAT IT WAS VERY LIKELY THE JACKET OF THE WIRE WAS SHEARED OFF AGAINST THE BLUNT METAL CANNULA OF THE COOK TROCAR NEEDLE DUE TO PERHAPS BECOMING ENTRAPPED AGAINST A STONE OR POSSIBLY STICKY FROM THE CONTRAST. T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8855834 ↗