Universa G23374Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002233741), received between Nov 11, 2016 and Aug 4, 2022 — classified as 3 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. 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.

• InjuryAug 4, 2022Break; Break

  AS REPORTED, A UNIVERSA SOFT URETERAL STENT FRAGMENTED WHILE INDWELLING IN THE PATIENT AND DURING REMOVAL. THE DEVICE WAS INITIALLY PLACED (B)(6) 2021 IN THE LEFT URETER USING A 10FR CYSTOSCOPE. ALL SEPARATED FRAGMENTS OF THE DEVICE WERE ABLE TO BE REMOVED VIA SCOPE (B)(6) 2022. DURING SUBSEQUENT INSPECTION OF THE DEVICE BY THE USER, THE DEVICE FRAGMENTS WERE EASILY CRUMBLED. THE PATIENT WAS HOSPITALIZED IN ACCORDANCE WITH THE PRE-OPERATIVE PLAN FOR STENT REMOVAL. THE DEVICE SEPARATION DID NOT CONTRIBUTE TO ANY PROLONGED HOSPITALIZATION OR ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15169407 ↗
• MalfunctionFeb 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE USING A UNIVERSA SOFT URETERAL STENT, THE END OF THE STENT WAS SPLIT. THE SPLIT WAS NOTICED IMMEDIATELY AFTER THE DEVICE WAS REMOVED FROM THE PACKAGE. ANOTHER SAME TYPE DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO PATIENT CONTACT THEREFORE NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670654 ↗
• InjuryAug 17, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE STRING SNAPPED DURING IMPLANTATION OF THE UNIVERSA SOFT URETERAL STENT SET. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT INTACT AND REPLACED IT. NO SECTION OF THE DEVICE REMAINS INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED. AS REPORTED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT, DEVICE AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799880 ↗
• InjuryNov 11, 2016Material Separation; Material Separation

  A PATIENT WITH A LARGE OBSTRUCTING RIGHT UPJ STONE UNDERWENT STENT PLACEMENT. WHEN PLACING THE STENT, THE STRING ON THE STENT KEPT FRAYING AND EVENTUALLY BROKE INSIDE THE PATIENT'S BLADDER. THE SURGEON WAS ABLE TO RETRIEVE THE REMAINING STRING WHICH ADDED MORE TIME IN SURGERY UNDER ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 6096635 ↗