Universa G49906Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002499062), received between Aug 8, 2014 and Aug 14, 2020 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2020Migration; Migration

  IT WAS REPORTED, AFTER A URETERAL LITHOTRIPSY, A UNIVERSA FIRM URETERAL STENT SET WAS PLACED, AND THE STENT MIGRATED. THE PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO URETERAL CALCULUS. THE STENT LENGTH WAS SELECTED BECAUSE THE CUSTOMER "NORMALLY USES THIS LENGTH." AFTER THE STENT WAS PLACED ONLY THE PIGTAIL IN THE BLADDER WAS CONFIRMED AS FORMING CORRECTLY. ON (B)(6) 2020, THE PATIENT CLAIMED TO HAVE CONSTANT URINE LEAKAGE. AN EXAMINATION OF THE PATIENT 3-4 DAYS AFTER PLACEMENT FOUND THE "STENT MIGRATED AT THE URETHERAL ORIFICE". THE STENT WAS REPLACED WITH A NEW STENT. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408574 ↗
• MalfunctionJul 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 8764224 ↗
• MalfunctionFeb 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301125 ↗
• InjuryMar 26, 2018Material Fragmentation; Material Fragmentation

  AN HHS/FDA SUS VOLUNTARY EVENT REPORT REFERENCE: MW5075113 WAS RECEIVED. IT WAS REPORTED THAT A URETERAL STENT FROM THE UNIVERSA FIRM URETERAL STENT SET BROKE DURING A PROCEDURE. THE STENT AND THE BROKEN PIECE OF THE STENT WERE RETRIEVED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE EVENT, PATIENT DEMOGRAPHICS AND MEDICAL HISTORY, AVAILABILITY OF IMAGES OF THE PROCEDURE, AND WHETHER OR NOT THE DEVICE IS AVAILABLE FOR RETURN. IT HAS BEEN STATED THAT THE DEVICE WILL BE RETURNED AND THAT THE FACILITY DOES NOT HAVE ANY FURTHER DETAILS THAT THEY CAN PROVIDE REGARDING THE EVENT OR THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7370246 ↗
• MalfunctionAug 8, 2017Break

  IT WAS REPORTED THE PHYSICIAN INDICATED HE HAD DIFFICULTY APPROXIMATELY 3 TIMES IN ONE WEEK WITH THE TETHER BREAKING. ALSO, THIS HAD BEEN OCCURRING OFF AND ON IN THE PAST MONTH AND A HALF. NO LOT # OF THE DEVICE WAS GIVEN. THE PHYSICIAN KEEPS THE TETHER ON THE UNIVERSA FIRM URETERAL STENT WHEN PLACING IN THE PATIENT AND THEN USES THE TETHER FOR CORRECT POSITIONING. THE DISTRICT MANAGER INDICATED SHE WAS ALSO NOTIFIED OF THIS SAME EVENT OCCURRING ON MONDAY, (B)(6) 2015. THE STENTS REMAIN PLACED WITH NO HARM TO THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774273 ↗
• MalfunctionJun 7, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT THE UNIVERSAL FIRM URETERAL STENT SET WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6617226 ↗
• InjuryAug 8, 2014Material Separation

  THE PHYSICIAN WAS PLACING THE STENT UNDER DIRECT CYSTOSCOPIC GUIDANCE. THE PHYSICIAN ADVANCED IT UP INTO THE KIDNEY AND WITHDREW THE WIRE TO GET THE PROXIMAL END TO COIL, WHICH IT DID FINE. THE PHYSICIAN THEN BACKED THE CYSTOSCOPE TO THE BLADDER NECK AND ADVANCED THE STENT INTO THE BLADDER UNTIL I COULD IDENTIFY THE PUSHER AND DISTAL END OF THE STENT AT THE BLADDER NECK. THE PHYSICIAN CUT AND PULLED THE DANGLER. INSTEAD OF SLIDING RIGHT OUT, THE "DANGLER" (TETHER) JUST SAWED THROUGH THE STENT ITSELF LIKE A KNIFE CUTTING BUTLER. THE PHYSICIAN LEFT IN IT SINCE IT SHOULDN'T REALLY AFFECT THE FUNCTION OF THE STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 4203641 ↗