GLIDEWIRE GR1805Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350772855), received between Jun 27, 2018 and Sep 3, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJan 30, 2019Fracture; Fracture

  THE USER FACILITY REPORTED THAT DURING THE RADIOLOGY INSERTION OF CCIP LINE, IT WAS DISCOVERED THAT THE OUTER MANTLE OF THE GLIDEWIRE WAS REMOVED FROM THE GUIDE IN THE PATIENT'S ARM. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 28, 2019. THE PROCEDURE WAS A PICC LINE. THE MANTLE IS THE BLACK COVER PART. THE MANTLE OF THE GUIDEWIRE WAS STUCK IN THE PATIENTS ARM. THE OUTER MANTLE OF THE GUIDEWIRE WAS ABLE TO BE PULLED OUT. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PROCEDURE WAS STOPPED.

  Patient problems: No Code Available

  MAUDE report 8290365 ↗
• InjuryJun 27, 2018Fracture; Fracture

  THE USER FACILITY REPORTED BREAKAGE ON THE INVOLVED RF GUIDEWIRE DEVICE. THE PROCEDURE WAS A PERMA CATH INSERTION, UTILIZING THE RIGHT INTERNAL JUGULAR, WHICH WAS VERY TORTUOUS. ACCESS WAS OBTAINED WITH A MICROPUNCTURE KIT AND INTRODUCER 5FR, GLIDEWIRE UTILIZED VIA THE MICROPUNCTURE SHEATH INTRODUCER, NOT THE ACCESS NEEDLE. IT WAS NOTED AND APPEARED THE GLIDEWIRE TIP FRACTURED, WITH THE TIP REMAINING IN THE EXTERNAL JUGULAR VEIN, COILED, VERY TORTUOUS TINY VEIN, SUSPECTING PROBABLY INTIMA (THE INNERMOST COATING OF A VEIN OR ARTERY). IT WAS REPORTED THAT THE DOCTOR CHOOSE NOT TO INTERVENE AT THIS TIME FOR RETRIEVAL OF TIP. THE PATIENT WAS REPORTED TO BE "OK". IT WAS REPORTED THAT THE PERMACHATH INSERTION WAS SUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7642642 ↗