PTFE Coated Urological Guidewire M0066201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729005711), received between Sep 20, 2019 and Dec 21, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 18, 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.

• MalfunctionDec 21, 2020Fracture; Fracture

  PER CNF, IT WAS REPORTED THAT: WHEN THE 0.038 GUIDEWIRE ENCLOSED WITH THE 8FR URINARY DIVERSION STENT PREPARED FOR SJ STENT REPLACEMENT WAS INSERTED INTO THE 7FR SJ STENT THAT HAD ALREADY BEEN IMPLANTED INSIDE THE PATIENT, RESISTANCE WAS FELT AND THE STENT COULD NOT BE REMOVED. TRIED TO REMOVED IT IT AS IT WAS, THE GUIDE WIRE WAS TORN. THE REMAINING GUIDEWIRE IN THE SJ STENT THAT WAS SUBSEQUENTLY SHREDDED AND LEFT IN THE SJ STENT COULD BE REMOVED, SO IT WAS CHANGED TO A TERUMO RADIFOCUS GUIDEWIRE AND THE PROCEDURE OF URETERAL STENOSIS DILATATION AND 8 FR SJ STENT PLACEMENT WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11045779 ↗
• MalfunctionNov 24, 2020Fracture; Material Deformation; Fracture; Material Deformation

  PER EMAIL, IT WAS REPORTED THAT: AS THE DOCTOR WENT TO USE THE ITEM DURING A CASE, HE NOTICED THAT THE FIBER WAS FRACTURED IN THE PLASTIC HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892128 ↗
• MalfunctionMar 13, 2020Fracture; Fracture

  IT WAS REPORTED THE GUIDEWIRE BROKE OFF WHILE USING IT IN THE PATIENT. A PIECE OF THE GUIDEWIRE FELL OFF INSIDE THE PATIENT AND THEY WERE ABLE TO RETRIEVE IT. THEY USED ANOTHER OF THE SAME GUIDEWIRE TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829823 ↗
• MalfunctionSep 20, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE CUSTOMER INITIALLY REPORTED THAT "THE BAG WAS TORN, AND THE PRODUCT BAG INSIDE GOT DAMAGED/SCRATCHED". THE OBSERVATION MADE DURING OUR INVESTIGATION SHOWED THAT THE RETURNED POUCH HAD BEEN DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9098135 ↗