Universa G49942Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002499423), received between Jul 3, 2017 and Aug 13, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Break

  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

  MAUDE report 22794661 ↗
• MalfunctionJul 19, 2024Break; Break

  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

  MAUDE report 19785940 ↗
• InjuryFeb 8, 2023Calcified; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Calcified; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 16320197 ↗
• MalfunctionFeb 18, 2022Break; Break

  AS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY A UNIVERSAL SOFT URETERAL STENT WAS BEING USED. THE PHYSICIAN WANTED TO INSERT THE DEVICE INTO THE PATIENT'S URETER. WHEN THE OR NURSE OPENED THE DEVICE PACKAGE, THEY NOTICED THAT ONE SIDE OF THE PIGTAIL LOOP HAD RUPTURED. THE TETHER WAS CONFIRMED TO BE ATTACHED TO THE STENT WHEN THE PACKAGE WAS OPENED. 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 13560201 ↗
• MalfunctionMay 28, 2020Break; Break

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10095748 ↗
• MalfunctionMar 26, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9883417 ↗
• MalfunctionFeb 5, 2020Crack; Crack

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9672134 ↗
• MalfunctionDec 19, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 19DEC2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9494816 ↗
• MalfunctionJun 13, 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 8696061 ↗
• MalfunctionMay 29, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT IS REPORTED DURING A URETEROSCOPY USING A UNIVERSA SOFT URETERAL STENT SET, THE PHYSICIAN TESTED THE PRODUCT BEFORE THE PROCEDURE AND FOUND THAT THERE WAS A "CREASE" ON THE SIDE OF THE DRAINAGE HOLE. THIS DEVICE WAS NOT USED. THE PHYSICIAN OPENED A NEW STENT TO PLACE INTO THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651366 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT WHILE PREPARING TO PERFORM A CYSTOSCOPE URETERAL STENT IMPLANT USING A UNIVERSA SOFT URETERAL STENT SET, THE STENT PACKAGE WAS OPENED AND THE PHYSICIAN FOUND THAT THE STENT HAD A CRACK IN IT. THE FACILITY WILL NOT PROVIDE ANY FURTHER PATIENT INFORMATION DUE TO THEIR PRIVACY POLICIES. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE COMPLAINT DEVICE WAS NOT USED. THE PHYSICIAN USED AN ADDITIONAL NON-SPECIFIED DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285329 ↗
• MalfunctionAug 29, 2018Crack; Crack

  IT WAS REPORTED THE PHYSICIAN OPENED THE UNIVERSA SOFT URETERAL STENT SET AND FOUND THERE WAS A FISSURE IN THE END OF STENT. THUS, THE PHYSICIAN USED ANOTHER NEW USH-626 STENT TO FINISH THIS MEDICAL PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE "FISSURE" WAS FOUND PRIOR TO CONTACT ONCE PACKAGE WAS OPENED. STENT WAS CHECKED AND FISSURE FOUND WITHOUT ANOTHER DEVICE OR EQUIPMENT IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827150 ↗
• MalfunctionApr 13, 2018Torn Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A FISSURE IN THE FRONT END OF THE URETERAL STENT. IT WAS FURTHER NOTED THAT THE PROXIMAL COIL WAS TORN STARTING AT THE LAST SIDEPORT AND CONTINUING THROUGH THE END OF THE TUBING. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428698 ↗
• MalfunctionApr 13, 2018Material Deformation; Torn Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A FISSURE IN THE FRONT END OF THE URETERAL STENT. IT WAS FURTHER NOTED THAT THE PROXIMAL COIL WAS TORN STARTING AT THE LAST SIDEPORT AND CONTINUING THROUGH THE END OF THE TUBING. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428615 ↗
• MalfunctionApr 12, 2018Out-Of-Box Failure; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PHYSICIAN OPENED THE UNIVERSA SOFT URETERAL STENT SET AND FOUND A FISSURE IN THE FRONT END OF THE STENT. AS A RESULT, THE PHYSICIAN USED ANOTHER NEW UNIVERSA SOFT URETERAL STENT SET TO FINISH THIS MEDICAL PROCEDURE (URETERORENOSCOPY). THE COMPLAINT PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7427352 ↗
• MalfunctionApr 12, 2018Torn Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A FISSURE IN THE FRONT END OF THE URETERAL STENT. IT WAS FURTHER NOTED THAT STARTING AT THE FIRST SIDEPORT AND THROUGH THE TIP THE STENT WAS TORN. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7425727 ↗
• MalfunctionApr 12, 2018Torn Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A FISSURE IN THE FRONT END OF THE URETERAL STENT. IT WAS FURTHER NOTED THAT THERE WAS A TEAR STARTING AT THE FIRST SIDEPORT. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7425215 ↗
• MalfunctionApr 10, 2018Torn Material

  IT WAS REPORTED THAT URETERAL STENT HAD A FISSURE ON THE FRONT END. IT WAS FURTHER NOTED THAT THERE WAS A TEAR ON THE PROXIMAL COIL. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7417511 ↗
• MalfunctionDec 19, 2017Fracture; Fracture

  THE USER FACILITY REPORTED AFTER A URETEROSCOPIC LITHOTRIPSY PROCEDURE, UPON OPENING THE PACKAGE, THE NURSE FOUND A CRACK AT THE END OF THE UNIVERSA SOFT URETERAL STENT. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE PROCEDURE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED 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 7132746 ↗
• MalfunctionDec 14, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED DURING A URETERORENOSCOPY PROCEDURE, THE PHYSICIAN OPENED THE UNIVERSA SOFT URETERAL STENT SET AND FOUND THERE WAS A FISSURE AT THE END OF THE STENT. THE STENT SET WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN USED A NEW STENT SET TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116513 ↗
• MalfunctionNov 2, 2017Fracture; Fracture

  THE AREA REPRESENTATIVE REPORTED DURING A URETERORENOSCOPY PROCEDURE ON A (B)(6) MALE PATIENT, WHEN THE PHYSICIAN OPENED THE UNIVERSA SOFT URETERAL STENT IT WAS OBSERVED THAT THERE WAS A FISSURE IN THE FRONT END OF THE STENT. THEREFORE, THE STENT WAS NOT USED. THE PHYSICIAN OPENED ANOTHER NEW UNIVERSA SOFT URETERAL STENT AND USED IT TO FINISH THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6995702 ↗
• MalfunctionJul 21, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE UNIVERSA SOFT URETERAL STENT SET WAS CHOSEN TO PERFORM AN ENDOSCOPIC URETEROLITHOTRICIA PROCEDURE. HOWEVER, THE CATHETER WALL WAS FOUND TO BE BROKEN. THE ISSUE WAS DISCOVERED PRIOR TO USE, AND NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE REPORTED CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6733648 ↗
• MalfunctionJul 3, 2017Split; Split

  IT WAS REPORTED THAT PRIOR TO PERFORMING AN URETERORENOSCOPY, THE PHYSICIAN OPENED A UNIVERSAL SOFT URETERAL STENT SET AND FOUND A FISSURE IN THE FRONT END OF THE STENT. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE PHYSICIAN USED ANOTHER STENT SET TO COMPLETE THE PROCEDURE. 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 6683814 ↗