Universa G49969Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002499697), received between Jul 27, 2017 and Jun 20, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Split” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2022Break; Break

  AS REPORTED, DURING A URETEROSCOPY,LASER LITHOTRIPSY, INSERTION OF A UNIVERSA SOFT URETERAL STENT SET THE STENT BROKE IN PREPARATION FOR PLACEMENT. THE STENT TETHER WAS CUT AND WHILE REMOVING THE TETHER, THE END CURL OF THE STENT BROKE OFF. THIS OCCURRED PRIOR TO FEEDING THE STENT ONTO THE GUIDE WIRE, PRIOR TO ACTUAL PATIENT CONTACT. EXCESSIVE FORCE WAS NOT USED IN THE REMOVAL OF THE TETHER. ANOTHER STENT WAS OPENED AND THE TETHER REMOVED AND PLACED OVER THE GUIDE WIRE SUCCESSFULLY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743372 ↗
• MalfunctionApr 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE BLADDER END OF TWO UNIVERSA SOFT URETERAL STENTS SPLIT CONSECUTIVELY WHEN PLACING EACH OVER A WIRE. THE TETHER WAS REMOVED PRIOR TO PLACEMENT. A THIRD DEVICE WAS OPENED AND PLACED SUCCESSFULLY. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051481 ↗
• MalfunctionApr 12, 2018Split; Torn Material

  IT WAS REPORTED THAT THERE WAS A SPLIT IN THE FRONT END OF THE URETERAL STENT. IT WAS FURTHER NOTED THAT THE STENT WAS TORN STARTING AT THE FIRST SIDEPORT AND ENDING BEFORE GOING THROUGH THE TIP. 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 7425612 ↗
• MalfunctionJul 27, 2017Split; Split

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED TO UNDERGO PLACEMENT OF A UNIVERSA SOFT URETERAL STENT FOR AN UNSPECIFIED INDICATION. THE DEVICE WAS OPENED AND EXAMINED PRIOR TO USE. THE STAFF NOTICED THAT THE DEVICE HAD A SPLIT; THE DETAILS AND LOCATION OF THE SPLIT WERE NOT PROVIDED. THE DEVICE WAS REMOVED FROM THE FIELD AND A REPLACEMENT DEVICE WAS OBTAINED. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT CONTACT, ACCORDINGLY THERE ARE NO REPORTED ADVERSE PATIENT EVENTS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6747957 ↗