URO-GUIDE 5498526Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925002845), received between Sep 29, 2024 and Sep 29, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (4 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 16, 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.

• InjurySep 29, 2024Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF A DOUBLE J URETERAL STENT, DISLOCATION OCCURRED IN THE URINARY TRACT CAUSING UROSEPSIS. THE DEVICE WAS UNABLE TO CREATE AN ADEQUATE SEAL CURL IN THE UPPER URINARY TRACT, THUS SELF-DISLOCATING FROM THE RENAL PELVIS INTO THE BLADDER. FOLLOW-UP INFORMATION RECEIVED THAT PATIENT VISITED THE EMERGENCY DEPARTMENT WITH UROSEPSIS. THE PROCEDURE WAS A URETERAL BRACE PLACEMENT OR URETERAL CATHETERIZATION PERFORMED. NO DELAY DURING THE PROCEDURE, BUT PATIENT HAVING TO REPEAT THE PROCEDURE 2 TIMES FOR DISLOCATION OF THE URETERAL STENT. CUSTOMER REPORTED THE PRODUCT HAS NO ABNORMALITY OR DEFECT, BUT DEVICE DESIGNED IN SUCH A WAY THAT THE PROXIMAL INTRARENAL CURL DOES NOT FULLY CURL AND THEREFORE DOES NOT PROVIDE SUPERIOR ANCHORAGE AND DISLOCATION WITH HIGH PROBABILITY. THE DEVICE DISLOCATION CAUSED PROLONGED HOSPITALIZATION AND TREATMENT WITH INTRAVENOUS ANTIBIOTICS TO RESOLVE THE PATIENT'S SEPSIS CUSTOMER REFERS THAT SIMILAR EVENT OCCURRED IN OTHER 3 CASES IN THE MONTH.

  Patient problems: Sepsis

  MAUDE report 20330503 ↗
• InjurySep 29, 2024Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF A DOUBLE J URETERAL STENT, DISLOCATION OCCURRED IN THE URINARY TRACT CAUSING UROSEPSIS. THE DEVICE WAS UNABLE TO CREATE AN ADEQUATE SEAL CURL IN THE UPPER URINARY TRACT, THUS SELF-DISLOCATING FROM THE RENAL PELVIS INTO THE BLADDER. FOLLOW-UP INFORMATION RECEIVED THAT PATIENT VISITED THE EMERGENCY DEPARTMENT WITH UROSEPSIS. THE PROCEDURE WAS A URETERAL BRACE PLACEMENT OR URETERAL CATHETERIZATION PERFORMED. NO DELAY DURING THE PROCEDURE, BUT PATIENT HAVING TO REPEAT THE PROCEDURE 2 TIMES FOR DISLOCATION OF THE URETERAL STENT. CUSTOMER REPORTED THE PRODUCT HAS NO ABNORMALITY OR DEFECT, BUT DEVICE DESIGNED IN SUCH A WAY THAT THE PROXIMAL INTRARENAL CURL DOES NOT FULLY CURL AND THEREFORE DOES NOT PROVIDE SUPERIOR ANCHORAGE AND DISLOCATION WITH HIGH PROBABILITY. THE DEVICE DISLOCATION CAUSED PROLONGED HOSPITALIZATION AND TREATMENT WITH INTRAVENOUS ANTIBIOTICS TO RESOLVE THE PATIENT'S SEPSIS. CUSTOMER REPORTS 3 OTHER SUCH EVENTS OCCURRING IN THE MONTH.

  Patient problems: Sepsis

  MAUDE report 20330497 ↗
• InjurySep 29, 2024Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF A DOUBLE J URETERAL STENT, A DISLOCATION OCCURRED IN THE URINARY TRACT CAUSING UROSEPSIS. THE DEVICE WAS UNABLE TO CREATE AN ADEQUATE SEAL CURL IN THE UPPER URINARY TRACT, THUS SELF-DISLOCATING FROM THE RENAL PELVIS INTO THE BLADDER. FOLLOW-UP INFORMATION RECEIVED THAT PATIENT VISITED THE EMERGENCY DEPARTMENT WITH UROSEPSIS. THE PROCEDURE WAS A URETERAL BRACE PLACEMENT OR URETERAL CATHETERIZATION PERFORMED. NO DELAY DURING THE PROCEDURE, BUT PATIENT HAVING TO REPEAT THE PROCEDURE 2 TIMES FOR DISLOCATION OF THE URETERAL STENT. CUSTOMER REPORTED THE PRODUCT HAS NO ABNORMALITY OR DEFECT, BUT DEVICE DESIGNED IN SUCH A WAY THAT THE PROXIMAL INTRARENAL CURL DOES NOT FULLY CURL AND THEREFORE DOES NOT PROVIDE SUPERIOR ANCHORAGE AND DISLOCATION WITH HIGH PROBABILITY. THE DEVICE DISLOCATION CAUSED PROLONGED HOSPITALIZATION AND TREATMENT WITH INTRAVENOUS ANTIBIOTICS TO RESOLVE THE PATIENT'S SEPSIS. CUSTOMER REFERS THAT SIMILAR EVENT OCCURRED IN OTHER 3 CASES IN THE MONTH.

  Patient problems: Sepsis

  MAUDE report 20330495 ↗
• InjurySep 29, 2024Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A DIFFICULT URETHRAL STENT PLACEMENT ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL PRESENTING WITH UROSEPSIS ON (B)(6) 2024. AN ABDOMINAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND IT WAS DISCOVERED THAT THE STENT HAD MIGRATED (FROM RENAL PELVIS INTO THE BLADDER) AND THEREFORE HAD TO BE REMOVED AND A SIMILAR DEVICE PLACED. THE DOCTOR REPORTS NO ABNORMALITIES WITH RESPECT TO THE STANDARD DESIGN OF THE DEVICE (PRODUCT APPARENTLY NOT COMPROMISED) HOWEVER, THE DOCTOR COMPLAINS OF DIFFICULTIES IN THE PLACEMENT OF THE STENT AND UNABLE TO CREATE AN ADEQUATE SEAL CURL IN THE UPPER URINARY TRACT, THUS LED TO MIGRATING OF THE DEVICE. THERE WERE NO DELAYS REPORTED DURING PROCEDURE.

  Patient problems: Sepsis

  MAUDE report 20330487 ↗