Universa G49866Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002498662), received between Apr 3, 2017 and Feb 11, 2026 — classified as 3 injuries, 11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT THE USER FOUND THE PACKAGING OF A UNIVERSA FIRM URETERAL STENT SET WAS NOT SEALED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER 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 24315593 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED, ONE OF THE PIGTAILS OF A UNIVERSA FIRM URETERAL STENT SET SEPARATED FROM THE STENT. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. A NEW STENT WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE IN THE URETER. 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 23958196 ↗
• MalfunctionAug 21, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: PROCEDURE WAS COMPLETED WITH A NEW DEVICE. IT IS UNKNOWN HOW THE STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862683 ↗
• MalfunctionJan 7, 2022Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, THE INNER PACKAGING OF A UNIVERSA FIRM URETERAL STENT SET WAS NOT SEALED PROPERLY. THERE WAS NO PATIENT IMPACT AS THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13194978 ↗
• MalfunctionDec 15, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 10FEB2022: THE STENT COMPLETELY SEPARATED ON THE NON-TETHER SIDE OF THE DEVICE. THE TETHER WAS ATTACHED TO THE STENT WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012081 ↗
• InjuryMay 11, 2021Difficult to Remove; Difficult to Remove

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11807322 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A UNIVERSA FIRM URETERAL STENT WAS IMPLANTED IN A PATIENT ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT FELT UNWELL AND RETURNED TO THE HOSPITAL FOR EXAMINATION. IT WAS DISCOVERED THAT PREVIOUSLY DIAGNOSED HYDRONEPHROSIS HAD BEEN AGGRAVATED, AND THE STONE WAS ATTACHED TO THE STENT. THE PATIENT HAD NOT RETURNED TO THE HOSPITAL FOR REVIEW DURING THIS PERIOD. THE PHYSICIAN ARRANGED FOR SURGERY, REMOVED THE STENT AFTER A LASER LITHOTRIPSY, AND EXCHANGED IT FOR A NEW DEVICE. THERE WAS NO TREATMENT REQUIRED FOR THE HYDRONEPHROSIS, WHICH SPONTANEOUSLY RESOLVED FOLLOWING THE STENT EXCHANGE. THE PATIENT WAS KNOWN TO BE IN "GOOD CONDITION."

  Patient problems: No Code Available; Renal Impairment

  MAUDE report 11258640 ↗
• MalfunctionNov 6, 2020Break; Break

  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 10804643 ↗
• MalfunctionJul 10, 2020Crack; Crack

  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 10257045 ↗
• MalfunctionJul 1, 2020Crack; Crack

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, A CRACK IN THE PIGTAIL END OF THE UNIVERSA FIRM URETERAL STENT SET WAS FOUND WHEN THE PACKAGING WAS OPENED. THE TETHER HAD NOT BEEN REMOVED FROM THE STENT. ANOTHER UNIVERSA FIRM URETERAL STENT SET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218404 ↗
• MalfunctionJan 18, 2019Crack; Crack

  IT WAS INITIALLY REPORTED DURING AN ENDOSCOPIC HOSE SURGERY, THE USER OPENED THE UNIVERSA FIRM URETERAL STENT SET PACKAGE AND FOUND OUT THE PIGTAIL END WAS BROKEN. ADDITIONAL INFORMATION RECEIVED ON 17-JAN-2019, ADVISING THE PIGTAIL WAS CRACKED AND ANOTHER SAME DEVICE TYPE WAS USED TO COMPLETE THE PROCEDURE. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT AND THE STENT WAS NOT USED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261745 ↗
• InjuryJul 3, 2018Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

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

  Patient problems: Laceration(s); No Code Available

  MAUDE report 7657870 ↗
• MalfunctionApr 12, 2018Crack; Torn Material

  IT WAS REPORTED THAT THE UNIVERSA FIRM URETERAL STENT WAS ALREADY CRACKED/TORN WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WAS NO IMPACT TO THE PATIENT OR USERS.

  Patient problems: No Patient Involvement

  MAUDE report 7426615 ↗
• MalfunctionApr 3, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE USER FACILITY THAT UPON OPENING THE PACKAGE THE TIP OF THE STENT WAS FOUND DETACHED. THIS INCIDENT OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6454040 ↗