SureGlide 35BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925005730), received between Jun 16, 2021 and Nov 11, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryNov 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, APPROXIMATELY 0.5CM PIECE OF THE LINING OF A GUIDE WIRE BROKE OFF FROM THE GUIDE WIRE AND WAS IN THE PATIENT'S BODY, UNTIL THE SURGEON REMOVED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658923 ↗
• MalfunctionOct 15, 2024

  APPROXIMATELY 0.5CM PIECE OF THE LINING OF A GUIDE WIRE BROKE OFF FROM THE GUIDE WIRE AND WAS IN THE PATIENT'S BODY, UNTIL THE SURGEON REMOVED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450930 ↗
• InjuryJun 16, 2021Material Separation; Material Separation

  IT IS REPORTED A PATIENT HAD A LEFT URETEROSCOPY WITH STENT FOR THE INDICATION OF LEFT URETERAL STONE (B)(6) 2020 USING A SURE GLIDE GUIDEWIRE AND AN HOLMIUM LASER (THE LASER SETTINGS WERE: 800 MJ AND 8 HZ. JOULES: 263.20, PULSES: 329, DURATION: 41 SECONDS). AFTER THE PROCEDURE, THE PATIENT EXPERIENCED URINARY URGENCY, FREQUENCY, AND URETHRAL PAIN. AN UNSPECIFIED TIME LATER, THE PATIENT HAD AN ULTRASOUND AND IT WAS FOUND THAT THE PATIENT HAD RETAINED A PORTION OF THE WIRE. THE PATIENT HAD ANOTHER URETEROSCOPY PROCEDURE (B)(6) 2021 TO TRY TO RETRIEVE THE BROKEN GUIDEWIRE WITH NO SUCCESS. THE PATIENT WAS THEN BOOKED FOR A LOWER URETERAL POLE STENT, UPPER POLE URETER URETEROSCOPY, REMOVAL OF FOREIGN BODY IN THE DISTAL URETER OF THE UPPER POLE URETER, URETERAL STENT IN UPPER POLE URETER AND REMOVAL OF STENT IN LOWER POLE AT THE LOCAL HOSPITAL TO HAVE THE DEVICE FRAGMENT REMOVED (B)(6) 2021 WHICH WAS SUCCESSFUL. THE PATIENT HAD A STENT PLACED AND CAME BACK SEVERAL WEEKS LATER TO HAVE THE STENT REMOVED AND IS NOW DOING FINE. NO FURTHER PROBLEMS. THE DEVICE FRAGMENT THAT WAS REMOVED FROM THE PATIENT WAS SENT TO PATHOLOGY. IT MEASURED 3.6CM X 0.1CM AND CAME BACK AS HYDROPHILIC NITINOL CORE

  Patient problems: Foreign Body In Patient

  MAUDE report 12014265 ↗