Universa G49977Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002499772), received between Apr 12, 2018 and Feb 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026

  6FR COOK MEDICAL STENT- TEAR IN THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363961 ↗
• MalfunctionJul 9, 2024Break; Material Separation; Break; Material Separation

  AS REPORTED, A 'UNIVERSA SOFT URETERAL STENT SET' WAS BROKEN. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19703374 ↗
• MalfunctionOct 1, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A UNIVERSA SOFT URETERAL STENT SET WAS USED DURING A CYSTOSCOPY, RIGHT URETEROSCOPY, RIGHT URETERAL STENT PLACEMENT PROCEDURE. THE PHYSICIAN STATED IT WAS "BROKEN". A NEW STENT FROM THE SAME LOT WAS USED AND WORKED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849348 ↗
• MalfunctionAug 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, PRIOR TO A URETEROSCOPY WITH A STENT PLACEMENT PROCEDURE, A UNIVERSA SOFT URETERAL STENT SET WAS INSPECTED, AND UPON INSPECTION IT WAS FOUND THAT THERE WAS A CRACK IN THE LINING. THIS WAS FOUND BEFORE IT MADE PATIENT CONTACT. ANOTHER UNIVERSA SOFT URETERAL STENT SET WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8911746 ↗
• MalfunctionApr 13, 2018Torn Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A SMALL TEAR ON THE DISTAL END OF THE URETERAL STENT. IT WAS FURTHER NOTED THAT THE PROXIMAL COIL WAS TORN STARTING AT THE LAST SIDEPORT AND CONTINUING THROUGH THE END OF THE TUBING. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428532 ↗
• MalfunctionApr 12, 2018Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, A SMALL TEAR WAS FOUND ON THE URETERAL STENT. IT WAS FURTHER NOTED THAT THE STENT WAS TORN STARTING AT THE FIRST SIDE-PORT AND STOPPED BEFORE GOING THROUGH THE TIP. THE CUSTOMER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424734 ↗