PTFE Coated Urological Guidewire M0066201000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729011408), received between Sep 10, 2020 and Aug 23, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionAug 23, 2021Fracture; Fracture

  PER CNF, IT WAS REPORTED THAT: PTFE GUIDEWIRE WAS GRIPPING ONTO THE WIRE DURING STENT DEPLOYMENT. DOCTOR FOUND IT DIFFICULT TO REMOVE THE GUIDEWIRE FROM THE STENT AS HE WAS DEPLOYING THE CONTOUR. THE STENT WAS GRIPPING ONTO THE GUIDEWIRE AND THE GUIDEWIRE UNRAVELLED A BIT. I?VE LODGED A SEPARATE COMPLAINT FOR THE CONTOUR STENT. HE FELT A LOT OF PRESSURE WHEN HE TRIED TO REMOVE THE GUIDEWIRE. DOCTOR REQUESTED TO OPEN ANOTHER NEW STENT AND GUIDEWIRE. HE MANAGED TO STENT PATIENT SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IS STABLE AND WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352377 ↗
• MalfunctionSep 10, 2020Material Integrity Problem; Material Integrity Problem

  PER EMAIL, IT WAS REPORTED THAT: THE MOVEABLE CORE WENT THROUGH THE OUTER SHEATH OF THE WIRE W 3 CONSECUTIVE WIRES. EVENTUALLY THE WIRES WERE THROWN AWAY AND AN ALTERNATIVE (NON-J TIP) WIRE WAS USED. DEVICE 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10518426 ↗
• MalfunctionSep 10, 2020Material Integrity Problem; Material Integrity Problem

  PER EMAIL, IT WAS REPORTED THAT: THE MOVEABLE CORE WENT THROUGH THE OUTER SHEATH OF THE WIRE W 3 CONSECUTIVE WIRES. EVENTUALLY THE WIRES WERE THROWN AWAY AND AN ALTERNATIVE (NON-J TIP) WIRE WAS USED. DEVICE 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10518355 ↗
• MalfunctionSep 10, 2020Material Integrity Problem; Material Integrity Problem

  PER EMAIL, IT WAS REPORTED THAT: THE MOVEABLE CORE WENT THROUGH THE OUTER SHEATH OF THE WIRE W 3 CONSECUTIVE WIRES. EVENTUALLY THE WIRES WERE THROWN AWAY AND AN ALTERNATIVE (NON-J TIP) WIRE WAS USED. DEVICE 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10518345 ↗