Universa G49874Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002498747), received between Apr 11, 2017 and Aug 5, 2026 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Unsealed Device Packaging

  Additional information received on 23AUG2026 stating that the device was unsealed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145047 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THE STENT OF THE UNIVERSA FIRM URETERAL STENT SET BROKE DURING PLACEMENT IN THE URETER. THE BREAK WAS DETECTED WHEN THE USER ADJUSTED THE STENT¿S LOCATION AND NOTICED BREAKAGE AFTER PULLING THE STENT OUT SLIGHTLY. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956912 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THE UNIVERSA FIRM URETERAL STENT SET'S STENT WAS BROKEN PRIOR AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE USER CUT OFF THE TETHER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456636 ↗
• MalfunctionJul 23, 2021Material Separation; Material Separation

  AS REPORTED, AFTER OPENING THE PACKAGE OF A UNIVERSA FIRM URETERAL STENT SET, THE STENT WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER NEW DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 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 12217586 ↗
• MalfunctionNov 10, 2020Fracture; Fracture

  AS REPORTED, THE USER OPENED THE PACKAGE FOR A UNIVERSA FIRM URETERAL STENT SET, AND THE TIP OF THE DEVICE WAS BROKEN. A PHOTO OF THE DEVICE PROVIDED BY THE USER APPEARS TO SHOW A PARTIAL SEPARATION ON THE PIGTAIL OF THE DEVICE. THE DEVICE WAS NOT USED ON THE PATIENT. THE USER CHANGED TO A NEW DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10815816 ↗
• MalfunctionJul 23, 2019Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  UPDATE 05AUG2019: THE USER CUT THE TETHER DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817919 ↗
• MalfunctionApr 12, 2018Split; Torn Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A SPLIT IN THE URETERAL STENT. IT WAS FURTHER NOTED THAT ONE COIL WAS TORN IN TWO LOCATIONS. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7425771 ↗
• MalfunctionApr 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND FOUND THE UNIVERSA FIRM URETERAL STENT SET WAS SEPARATED INTO TWO PARTS. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT; THEREFORE, THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6481741 ↗