PTFE Coated Urological Guidewire M0066201200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729056676), received between Aug 28, 2020 and Nov 3, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Fracture; Fracture

  MATERIAL CHANGE TO COMPLAINT: NO VALUE FOUND RELATED PRODUCT MODEL #: 620-120. RELATED PRODUCT SERIAL #: NO VALUE FOUND. RELATED PRODUCT UPN #: M0066201200. RELATED PRODUCT BATCH/LOT: 0008872553. RELATED PRODUCT FAMILY: STANDARD TEFLON. MATERIAL NUMBER: M0066201200. STERILE LOT NUMBER: NO VALUE FOUND. SOLD TO ACCOUNT NUMBER: NO VALUE FOUND. RETURNED PRODUCT EXPECTED: NO. BSC PRODUCT RETURN DATE: 2025-10-8. LOCATION DESCRIPTION: SENT TO SFMD. DEVICE/PROCEDURE OUTCOME: ORIGINAL DEVICE USED, PROCEDURE COMPLETED. PATIENT OUTCOME: 104: CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN. EVENT DESCRIPTION: ECN EVENT DESCRIPTION: DURING A STONE CASE, WHILST THE SURGEON WAS LASERING IN THE KIDNEY THE TIP OF THE PTFE GUIDEWIRE SNAPPED OFF THE END. THE SURGEON WAS UNABLE TO REMOVE THE GUIDEWIRE, AND THE PATIENT IS RETURNING FOR A SECOND PROCEDURE TO REMOVE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN. WHAT IS THE NEXT COURSE OF ACTION?: THE ACCOUNT HAS REQUESTED AN INVESTIGATION AND WOULD LIKE THE GUIDE WIRE TO BE COLLECTED FOR ANALYSIS. THEY WOULD LIKE TO KNOW WHAT CAUSED THE GUIDEWIRE TO SNAP. PATIENT PRESENT AT TIME OF EVENT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444813 ↗
• MalfunctionJun 13, 2022Fracture; Fracture

  PER EMAIL, IT AS REPORTED THAT: DOCTOR FOUND THE DEVICE STUCK INSIDE DURING THE SURGERY. ADDITIONAL INFORMATION - (B)(6) 2022. WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? NO. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? NO. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? YES. WILL THE DEVICE BE RETURNED FOR ANALYSIS? YES. WHAT IS THE LOT# FOR THE DEVICE? WROTE ON CNF FORM. WHAT ACTIONS WERE PERFORMED ON THE GUIDEWIRE TO PREPARE THE GUIDEWIRE FOR USE? PUSH POLARIS ULTRA INTO THE URETER. WERE ANY PROBLEMS NOTED DURING PREPARATION? NO. WAS THE GUIDEWIRE PREPPED PROPERLY ACCORDING TO THE IFU? YES. LIST/NAME ANY DEVICE THAT WAS USED WITH THE GUIDEWIRE. POLARIS ULTRA. WAS THERE DIFFICULTY ADVANCING THE DEVICES OVER THE GUIDE WIRE? YES. WHAT BRAND/MANUFACTURER/SIZE OF CATHETER WAS USED FOR THE PROCEDURE? BOSTON NAVIGATOR HD SHEATH. WHAT WAS THE INTENDED PROCEDURE? PUSH POLARIS ULTRA INTO THE URETER. WHAT WAS THE SEQUENCE OF EVENTS DURING THE PROCEDURE? PUT ON GUIDEWIRE, AND THEN PENETRATE POLARIS ULTRA. WAS THERE ANY DIFFICULTY ADVANCING THE GUIDEWIRE TOWARDS THE TARGET LESION? NO. IS THERE ANY TARGET LESI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681926 ↗
• MalfunctionAug 28, 2020Fracture; Material Deformation; Fracture; Material Deformation

  WHEN SCRUB TECH REMOVED WIRE FROM THE PLASTIC TUBE THE FLEXIBLE TIP WAS DETACHED FROM THE WIRE. PULLED ANOTHER OF THE SAME WIRE AND COMPLETED THE CASE. DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10465087 ↗