Universa G23406Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002234069), received between Aug 5, 2016 and Jan 13, 2025 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE UNIVERSA FIRM URETERAL STENT SET'S STENTS HAD SOME SORT OF WHITISH FILM WHEN THEY REMOVE FROM THE STERILIZED PACKAGING PRIOR TO USE IN AN UNKNOWN PROCEDURE. CUSTOMER PROVIDED TWO VIDEOS APPEARING TO SHOW A STENT BEING PLACED IN A BASIN OF CLEAR FLUID AND THEN THE STRAIGHTENER BEING USED TO STRAIGHTEN OUT THE STENT PIGTAILS. THE VIDEO THEN FOCUSES ON THE TIP OF THE STRAIGHTENER WHERE A SEMI TRANSLUCENT MATERIAL APPEARS TO HAVE ACCUMULATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21139161 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  AS REPORTED, DURING A URETEROSCOPY, THE STRING (TETHER) ON THE END OF A UNIVERSA FIRM URETERAL STENT SET WAS NOT SECURED ON THE STENT. THE TETHER WAS THREADED THROUGH THE STENT. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO MAKING CONTACT WITH THE PATIENT AND IT WAS NOT USED. THE DEVICE WAS RETURNED 25MAR2021 AND INSPECTION OF THE DEVICE FOUND THE TETHER HAD SEPARATED AND WAS RETURNED IN TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701678 ↗
• InjuryDec 30, 2020Adverse 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: Sepsis; Urinary Tract Infection

  MAUDE report 11098808 ↗
• InjuryMay 1, 2020Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED ON 12MAY2020: A URETERAL STENT WAS PLACED ON (B)(6) 2020 IN A 58 YEAR OLD MALE PATIENT. THE FINAL REMOVAL PROCEDURE OCCURRED ON (B)(6) 2020.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10017212 ↗
• MalfunctionDec 31, 2019Migration; Migration

  ADDITIONAL INFORMATION PROVIDED 09JAN2020 CLARIFIES THAT THERE WERE ONLY TWO PATIENTS/CASES INVOLVED (AND NOT FIVE AS PREVIOUSLY REPORTED). THESE CASES ARE REPORTED IN PATIENT IDENTIFIER (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536311 ↗
• MalfunctionDec 31, 2019Migration; Migration

  ADDITIONAL INFORMATION RECEIVED ON 31JAN2020: IT WAS CONFIRMED THAT THERE WERE 6 TOTAL COMPLAINTS (B)(4)) OF STENTS MIGRATING IN PATIENTS, MAKING REMOVAL MORE DIFFICULT. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536302 ↗
• MalfunctionDec 31, 2019Migration; Migration

  IT WAS INITIALLY REPORTED, DURING A PERCUTANEOUS REMOVAL OF A UNIVERSA FIRM URETERAL STENT, THE STENT MIGRATED EITHER UP INTO THE KIDNEY OR DOWN INTO THE BLADDER. IT WAS DIFFICULT TO REMOVE THE STENT. THERE WERE SIMILAR COMPLAINTS IN FIVE PATIENTS (PATIENT REFERENCE (B)(6)). IT WAS REPORTED THAT THE STENT PIGTAILS FAILED TO HOLD THE DEVICE IN PLACE. FURTHER COMMUNICATION WITH THE ASSOCIATED COMPANY REPRESENTATIVE NOTED THE EXACT NUMBER OF PATIENTS/CASES WAS UNKNOWN. THE CUSTOMER REPORTED TWO DIFFERENT LOT NUMBERS, BUT THE QUANTITY FROM EACH LOT IS UNKNOWN. THE MANUFACTURER INQUIRED WHETHER THE STENTS WERE REMOVED PERCUTANEOUSLY OR TRANSURETHRALLY , AND THE REP BELIEVES THEY WERE REMOVED TRANSURETHRALLY. ALTHOUGH, THIS INFORMATION IS STILL BEING CONFIRMED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE OF THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536265 ↗
• MalfunctionAug 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871356 ↗
• InjuryOct 26, 2018Biocompatibility; Biocompatibility

  IT WAS REPORTED, THE PATIENT GOT THE UNIVERSA FIRM URETERAL STENT ON (B)(6) 2018. DURING A STENT REMOVAL PROCEDURE, THEY WERE UNABLE TO REMOVE THE STENT BECAUSE OF MANY ENCRUSTATIONS ON THE STENT. A SECOND PROCEDURE HAD TO BE SCHEDULED, WHERE THEY USED EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) TO GET THE INCRUSTATIONS OFF THE STENT, TO GET IT OUT. THEY FINALLY SUCCEEDED WITH OUT ANY PAIN FOR THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8009806 ↗
• MalfunctionOct 8, 2018Break; Break

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942983 ↗
• MalfunctionApr 12, 2018Break; Break

  IT WAS REPORTED THAT THE UNIVERSA FIRM URETERAL STENT WAS PLACED IN THE PATIENT DURING A PROCEDURE, BUT THE TETHER RIPPED OFF AND HAD TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 Consequences Or Impact To Patient

  MAUDE report 7425866 ↗
• InjuryDec 27, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, WHILE ATTEMPTING TO ADJUST THE STENT THE TETHER BROKE ON THE UNIVERSA FIRM URETERAL STENT INSIDE THE PATIENTS BODY. THEY WERE ABLE TO RETRIEVE THE TETHER. DUE TO THE BREAKAGE OF THE TETHER THEY WERE UNABLE TO ADJUST THE PIGTAIL AND HAD TO TURN THE PATIENT ON THEIR BACK AND ADJUST THE PIGTAIL THROUGH THE URETHRA, WHICH RESULTED IN LONGER OPERATING TIME. THERE WERE NO ADDITIONAL ADVERSE EFFECTS TO THE PATIENT. REQUESTED ADDITIONAL INFORMATION REGARDING THE ADDITIONAL TIME IT TOOK THEM TO COMPLETE THE PROCEDURE. THE CUSTOMER INDICATED THE DEVICE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7147392 ↗
• MalfunctionAug 10, 2017Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE USER FACILITY REPORTED DURING A URETEROSCOPY PROCEDURE AND PRIOR TO USE, THE UNIVERSA FIRM URETERAL STENT SET WAS FOUND TO NOT HAVE AN OPENING ON ONE END DUE TO THE OPENING WAS PINCHED. THIS DEVICE WAS NOT USED. AS REPORTED, NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS REPORTED DEVICE ISSUE. NO SECTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS DEVICE ISSUE. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT FILING.

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

  MAUDE report 6783946 ↗
• MalfunctionAug 9, 2017Material Integrity Problem

  THE PROXIMAL PIG TAIL OF THE URETER STENT DID NOT HAVE THE RIGIDITY TO FORM THE PIG TAIL. IT WOULD NOT CURL APPROPRIATELY. DURING REMOVAL, THE TETHER ON THE DEVICE STRETCHED AND SNAPPED. WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, FRAGMENTS OF THE TETHER HAD TO BE REMOVED FROM THE PATIENT WITH FORCEPS. THE BROKEN TETHER AND FRAGMENTS WERE REPORTED ON MDR# 1820334-2015-00842. THE PHYSICIAN ELECTED TO USE A SECONDARY STENT (ANOTHER MANUFACTURER) AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6777262 ↗
• MalfunctionAug 8, 2017Break

  THE INFORMATION RECEIVED INDICATED THAT THE TETHER BROKE DURING STENT DEPLOYMENT/PLACEMENT. AS THE PHYSICIAN WAS PULLING BACK ON THE STENT TO POSITION IT, THE TETHER BROKE. THE BROKEN PIECE OF THE TETHER WAS REMOVED FROM THE PATIENT BY HAND AND ONLY THE STENT REMAINS INSIDE THE PATIENT AS INTENDED. ACCORDING TO THE INITIAL REPORTER THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS RELATED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6774324 ↗
• MalfunctionAug 3, 2017Break

  THE INFORMATION RECEIVED INDICATED THAT DURING LASER LITHOTRIPSY WITH STENT PLACEMENT, THE TETHER STRING OF THE STENT BROKE. THE STENT WAS PLACED IN A 19 FRENCH CYSTOSCOPE- STORZ HOTKINS II, THE SCOPE WAS TOO SMALL FOR THE STENT PUSHER TO GO THROUGH. THE PHYSICIAN USED "A LOT" OF FORCE TO ADVANCE THE PUSHER AFTER STENT PLACEMENT AND IT GOT STUCK. THE PHYSICIAN TRIED TO BACK THE STENT OFF AND WAS PULLING ON THE TETHER STRING AND THEN THE STRING BROKE. NO PIECES REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 6764396 ↗
• MalfunctionJun 30, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT PRIOR TO PERFORMING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN FOUND THAT THE TAPERED END THE UNIVERSA FIRM URETERAL STENT SET WAS CLOSED SHUT AND THEREFORE HE WAS UNABLE TO LOAD THE STENT ONTO THE WIRE. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED BUT AT THIS TIME IT IS NOT KNOWN IF THE PHYSICIAN USED ANOTHER STENT SET FROM SAME OR DIFFERENT LOT. THERE WAS NO KNOWN PATIENT HARM REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6682243 ↗
• MalfunctionJun 13, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE PHYSICIAN IMPLANTED THE UNIVERSA FIRM URETERAL STENT SET WITH THE TETHER ON; HOWEVER THE TETHER BROKE OFF FROM THE STENT. THE PHYSICIAN PLACED THE STENT AT THE INTENDED LOCATION. IT WAS FURTHER REPORTED THAT THE PATIENT WILL NEED A SUBSEQUENT PROCEDURE TO REMOVE THE STENT DUE TO TETHER BREAKING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6636095 ↗
• InjuryJun 13, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE PHYSICIAN IMPLANTED THE UNIVERSA FIRM URETERAL STENT SET WITH THE TETHER ON; HOWEVER THE TETHER BROKE OFF FROM THE STENT. THE PHYSICIAN PLACED THE STENT AT THE INTENDED LOCATION. IT WAS FURTHER REPORTED THAT THE PATIENT WILL NEED A SUBSEQUENT PROCEDURE TO REMOVE THE STENT DUE TO TETHER BREAKING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6636092 ↗
• InjuryMar 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN URETEROSCOPIC PROCEDURE. THE ATTENDING PHYSICIAN INDICATED THAT THE UNIVERSAL FIRM URETERAL (UFH) STENT THAT HAD BEEN IMPLANTED TWO WEEKS PRIOR, COULD NOT BE REMOVED FROM THE PATIENT. THE STENT COULD NOT BE REMOVED FROM URETER VIA THE BLADDER SO NEPHROSTOMY WAS IMPLANTED AND THE PATIENT WILL BE BROUGHT BACK TWO WEEKS LATER FOR REMOVAL VIA SKIN. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6427812 ↗
• MalfunctionDec 23, 2016Break; Break

  IT WAS REPORTED A TETHER BROKE WHEN ATTEMPTING TO REMOVE THE TETHER OFF THE STENT DURING A URETEROSCOPY WITH LASER AND BASKET STONE REMOVAL. REPORTEDLY THE PHYSICIAN LEAVES THE TETHER ON THE STENT AND THEN REPOSITIONS THE STENT WITH THE TETHER. THE STENT WAS REPORTED TO HAVE ALREADY BEEN REPOSITIONED WHEN THE BREAKAGE OF THE TETHER OCCURRED AND WAS REMOVED BY HAND WITHOUT INSTRUMENTATION. REPORTEDLY THE STENT WAS NOT REMOVED AND WAS REPORTED TO HAVE BEEN IMPLANTED ON (B)(6) 2016. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 6202462 ↗
• InjuryAug 5, 2016Break; Break

  IT WAS REPORTED THAT A TEETHER BROKE OFF DURING AN UNKNOWN PROCEDURE. THE PHYSICIAN WAS ABLE TO RETRIEVE AND REMOVE THE BROKEN PART. WE WERE ADVISED THAT THE STENT WAS STILL ABLE TO BE DEPLOYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 5849797 ↗