Universa G23405Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002234052), received between Feb 23, 2016 and Jan 27, 2023 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Material Separation; Material Separation

  AS REPORTED, THE TETHER FROM A UNIVERSA FIRM URETERAL STENT SET IS BROKEN. THE DEVICE WAS RETURNED AND ANALYZED BY THE MANUFACTURE AND IT WAS NOTED THE TETHER WAS BROKEN AND APPEARED TO HAVE BEEN TIED TO THE STENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND OUTCOME WAS REQUESTED BUT IS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16256372 ↗
• InjuryNov 16, 2021Migration; Migration

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821775 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 8609397 ↗
• InjuryMay 14, 2019Calcified; Deformation Due to Compressive Stress; Calcified; Deformation Due to Compressive Stress

  IT WAS INITIALLY REPORTED ON (B)(6) 2019, THE CUSTOMER HAS RECENTLY NOTICED SEVERE ENCRUSTATIONS OCCURRING ON THE UFH STENTS ALONG WITH FLATTENED DISTAL END OF STENTS. THEY HAD NOT RETAINED ANY DEVICES FOR INVESTIGATION. CUSTOMER WAS ASKED TO PLEASE RETAIN STENTS FOR ANALYSIS IF ISSUE OCCURS. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2019. THE COATING OF THE DEVICE WAS ACTIVATED WITH SALINE, ALTHOUGH IT IS UNKNOWN HOW LONG IT WAS ACTIVATED. THE DEVICE WAS ACCESSED THROUGH THE URETERIC ORIFICE. THE PATIENT HAS BEEN DIAGNOSED AS BEING A STONE FORMER, HAVING THE PRE-EXISTING CONDITION OF RENAL CALCULI. THE DEVICE WAS REMOVED, THEN REPLACED WITH DIFFICULTY. THERE ARE NO PHOTOS, IMAGES, OR VIDEOS AVAILABLE, NOR PATHOLOGY REPORTS. IT IS UNKNOWN IF ANY INTERVENTION, ADDITIONAL PROCEDURES, AND/OR MEDICATIONS HAVE BEEN ADMINISTERED. NEW INFORMATION WAS RECEIVED ON (B)(6) 2019: ON (B)(6) 2019 A LEFT URETEROSCOPY, LITHOTRIPSY, AND JJ STENT INSERTION WAS PERFORMED. ON (B)(6) 2019, ATTEMPTED STENT REMOVAL WAS UNSUCCESSFUL DUE TO EXTREME CALCIFICATION AROUND THE COIL OF THE STENT. ON (B)(6) 2019, THIS PATIENT IS SCHEDULED FOR ANOTHER ATTEMPTED REMOVAL OF STENT. BASED ON THE INFORMATION RECEI

  Patient problems: No Code Available

  MAUDE report 8608809 ↗
• MalfunctionAug 8, 2017Detachment Of Device Component

  AS REPORTED THE "DOCTOR ATTEMPTED TO PLACE THE STENT AND THE TETHER RIPPED OFF (THIS EMDR#1820334-2017-02226). A SECOND STENT WAS PLACED AND THE SAME THING HAPPENED (SEE EMDR#1820334-2017-02227). A THIRD STENT WAS PLACED AND THERE WAS NO ISSUE." 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 6775327 ↗
• MalfunctionAug 8, 2017Detachment Of Device Component

  AS REPORTED THE "DOCTOR ATTEMPTED TO PLACE THE STENT AND THE TETHER RIPPED OFF (SEE EMDR#1820334-2017-02226). A SECOND STENT WAS PLACED AND THE SAME THING HAPPENED (THIS EMDR#1820334-2017-02227). A THIRD STENT WAS PLACED AND THERE WAS NO ISSUE." 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 6775169 ↗
• MalfunctionAug 8, 2017Break

  THE INFORMATION RECEIVED INDICATED THAT A STENT TETHER BROKE AFTER PULLING ON IT WITH VERY LITTLE PRESSURE. THE STENT WAS NOT PLACED; ANOTHER ONE WAS OPENED AND USED ON THE PATIENT. ACCORDING TO THE INITIAL REPORTER A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6773206 ↗
• InjuryAug 16, 2016Break; Break

  PER (B)(4) REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT DURING A URETEROSCOPY A STENT BROKE. THE DEVICE BROKE WITHIN THE URETER AND NEEDED TO BE RETRIEVED.

  Patient problems: No Code Available

  MAUDE report 5878222 ↗
• InjuryAug 12, 2016Break; Break

  PER THE MW5063068, REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT DURING A URETEROSCOPY PROCEDURE THE STENT BROKE. ANOTHER STENT WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. AS OF THIS DATE, PATIENT OUTCOME IS UNKNOWN AS INFORMATION WAS NOT PROVIDED BY REPORTER.

  Patient problems: No Code Available

  MAUDE report 5872962 ↗
• MalfunctionMay 5, 2016Material Separation; Material Separation

  DURING A URETEROSCOPY PROCEDURE ON A MALE PATIENT, THE PHYSICIAN PLACED THE STENT. THE TETHER WAS OUTSIDE OF THE PATIENT AND AS THE PHYSICIAN WAS TYING A KNOT IN THE TETHER TO SHORTEN IT AND THE TETHER BROKE. THE PHYSICIAN HAD TO USE A PIECE OF THE TETHER THAT BROKE OFF TO EXTEND THE TETHER TO BE OUTSIDE OF THE PATIENT. THE TETHER HAD TO BE EXTENDED BECAUSE, IF THE PATIENT WERE TO GET AN ERECTION, THE TETHER WOULD HAVE BEEN LOST INSIDE THE PATIENT. THE UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5633401 ↗
• InjuryMar 8, 2016Break; Break

  THE UNIVERSA FIRM URETERAL STENT WAS PLACED IN THE PATIENT WITH INSTRUCTIONS FOR THE PATIENT TO REMOVE AFTER 72 HOURS. HOWEVER, THE TETHER ON THE STENT BROKE AND THE PATIENT HAD TO RETURN TO THE DOCTOR FOR REMOVAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT铠BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5485510 ↗
• InjuryFeb 23, 2016Material Separation; Material Separation

  A URETEROSCOPY WITH DOUBLE J STENT PLACEMENT WAS BEING PERFORMED ON THE MALE PATIENT. THE STENT WAS PLACED ON (B)(6) 2016. THE TETHER WAS LEFT ON THE STENT AND THE PHYSICIAN INSTRUCTED THE PATIENT TO REMOVE STENT USING THE TETHER AFTER 48 HOURS. SOMETIME WITHIN THE 48 HOUR PERIOD, THE TETHER BROKE AND WAS NOT FOUND IN THE PATIENT (PATIENT VOIDED TETHER). STENT WAS REMOVED VIA CYSTOSCOPY BY THE IMPLANTING PHYSICIAN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5454176 ↗