Universa G49933Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002499331), received between May 16, 2017 and Aug 2, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Break; Break

  AS REPORTED, DURING A ENDOSCOPIC URETHROTOMY, UPON OPENING THE PACKAGE OF A UNIVERSA SOFT URETERAL STENT SET, THE DEVICE WAS FOUND TO BE BROKEN. THE BREAK WAS FOUND ON THE TETHERED END OF THE STENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152784 ↗
• MalfunctionMar 9, 2022Material Separation; Material Separation

  AS REPORTED, WHEN ADVANCING A UNIVERSA SOFT URETERAL STENT OVER THE PUSHER, THE STENT SEPARATED. THE DEVICE DID NOT MAKE PATIENT CONTACT. A PHOTO OF THE DEVICE SHOWS THE SEPARATION OCCURRED AT THE PROXIMAL PIGTAIL AT THE NON-TETHER END. A NEW STENT SET WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713627 ↗
• MalfunctionFeb 18, 2022Break; Break

  AS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY A UNIVERSA SOFT URETERAL STENT WAS USED. THEY PHYSICIAN WANTED TO INSERT THE DEVICE INTO THE PATIENT'S URETERAL. WHEN THE OR NURSE OPENED THE DEVICE PACKAGE THEY NOTICED THAT ONE SIDE OF THE PIGTAIL LOOP WAS RUPTURED. THE PHYSICIAN USED ANOTHER NEW SAME TYPE DEVICE TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560099 ↗
• MalfunctionNov 10, 2021Break; Break

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787675 ↗
• MalfunctionDec 16, 2020Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11016803 ↗
• InjuryMay 18, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 10065185 ↗
• MalfunctionJun 6, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  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 8677316 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT THE CATHETER BROKE THE MOMENT IT WAS PUT ON THE GUIDE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682799 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED DURING A URETEROSCOPY AND LASER STONE FRAGMENTATION (URSL) PROCEDURE WHILE USING THE UNIVERSA SOFT URETERAL STENT SET THE PHYSICIAN FOUND THE PUSHER HAD BROKEN. AS REPORTED, HE USED ANOTHER NEW UNIVERSA SOFT URETERAL STENT SET TO FINISH THIS MEDICAL PROCEDURE AND WITHOUT DIFFICULTIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED CONCERNING THE PATIENT AND EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7678534 ↗
• MalfunctionAug 30, 2017Wrinkled; Wrinkled

  DURING AN UNSPECIFIED PROCEDURE, THE OPERATOR DETECTED THAT THE CATHETER OF UNIVERSA SOFT URETERAL STENT SET WAS WRINKLED. THE OPERATOR REMOVED THE STENT SET FROM THE PATIENT¿S BODY. AT THIS TIME IT IS UNKNOWN HOW THE INTENDED PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE 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 6829605 ↗
• MalfunctionMay 16, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING THE DIAGNOSTIC URETEROSCOPY PROCEDURE, WHEN THE PHYSICIAN WAS ABOUT TO REMOVE THE THREADS, A UNIVERSA SOFT URETERAL STENT SET WAS FOUND SEPARATED PRIOR TO USE. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT HARM REPORTED AND NO ADDITIONAL PROCEDURES WERE REQUIRED BECAUSE OF THIS FAILURE. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED OR NOT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568474 ↗