Universa G53693Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002536937), received between Apr 12, 2018 and Apr 7, 2023 — classified as 2 injuries, 2 malfunctions.

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 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.

• InjuryApr 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A SURGEON THOUGHT THAT HE MAY HAVE DAMAGED THE URETER WHILE TRYING TO PLACE A UNIVERSA SOFT URETERAL STENT [SET]. THE USER COMPLETED THE PROCEDURE WITH A DIFFERENT STENT BRAND AND LENGTH. A 0.35 GLIDE WIRE WAS USED IN CONJUNCTION WITH THIS DEVICE. NO DAMAGE TO THE STENT WAS NOTED. NONE OF THE TETHERS WERE REMOVED. THE USER DID NOT REPORT ANY NOTABLE RESISTANCE IN THE STENT. AN UNKNOWN NUMBER OF DEVICE USERS AT THE FACILITY HAVE NOTED THAT THE STENTS DO NOT SLIDE OVER ANY TYPE OF GUIDEWIRE. THE CUSTOMER INADVERTENTLY ORDERED ALL NON-AQ COATED STENTS WHICH FELT DIFFERENT TO THE USERS WHEN ADVANCING THE WIRE.

  Patient problems: Insufficient Information

  MAUDE report 16703264 ↗
• InjuryDec 1, 2020Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10928482 ↗
• MalfunctionAug 18, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS INITIALLY REPORTED, A UNIVERSA SOFT URETERAL STENT WAS FOUND TO BROKEN ON THE PROXIMAL END AFTER IT HAD BEEN REMOVED FROM ITS PACKAGE. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO MAKING CONTACT WITH THE PATIENT AND IT WAS NOT USED. A NEW STENT WAS OPENED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED 06AUG2020 AND IT WAS DISCOVERED THE STENT WAS TORN. IT WAS REPORTED THAT NO ADDITIONAL PROCEDURES OR ADVERSE EFFECTS RESULTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420176 ↗
• MalfunctionApr 12, 2018Break

  IT WAS REPORTED THAT ONE OF THE PIGTAILS WAS MISSING AND FOUND AT THE END OF THE PACKAGING WHEN THE NURSE REMOVED THE UNIVERSA SOFT URETERAL STENT SET FROM THE PACKAGING. SINCE THE STENT WAS BROKEN, IT WAS NOT USED, AND THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7427375 ↗