Universa G49941Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002499416), received between Apr 11, 2018 and Sep 17, 2026 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809176 ↗
• MalfunctionNov 3, 2023Break; 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 18069751 ↗
• MalfunctionMay 2, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED, DURING A STENT EXCHANGE PROCEDURE, THE WIRE GUIDE OF THE UNIVERSA SOFT URETERAL STENT SET UNRAVELED WHEN THE PHYSICIAN WAS REMOVING THE WIRE GUIDE AFTER THE STENT PLACEMENT. FLUOROSCOPY WAS REQUIRED TO DETERMINE NO RETAINED PIECES OF WIRE REMAINED IN PATIENT. 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 16854688 ↗
• MalfunctionAug 31, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A URETEROSCOPIC LITHOTRIPSY, ONE SIDE OF THE PIGTAIL LOOP WAS FOUND RUPTURED ON A UNIVERSA SOFT URETERAL STENT WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE TETHER WAS ATTACHED TO THE STENT WHEN THE PACKAGE WAS OPENED. DUE TO NOT BEING ABLE TO SEE THE TETHER ON THE DAMAGE STENT, IT CANNOT BE DETERMINED WHICH SIDE OF THE STENT THE DAMAGE WAS FOUND. THE DEVICE DID NOT MAKE PATIENT CONTACT. A DEVICE OF THE SAME TYPE WAS USED TO FINISH THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328477 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS INITIALLY REPORTED, DURING URETEROSCOPIC LITHOTRIPSY (URSL), WHEN THE PACKAGE OF A UNIVERSA SOFT URETERAL STENT SET WAS OPENED IT WAS DISCOVERED THAT ONE SIDE OF THE PIGTAIL LOOP HAD A "RUPTURE". ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTIES. THE STENT WAS RETURNED TO THE MANUFACTURER, AND INSPECTION OF THE RETURNED DEVICE FOUND THE THE STENT WAS TORN, ALMOST ENTIRELY AROUND THE CIRCUMFERENCE OF THE STENT. 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 13927728 ↗
• MalfunctionNov 15, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, PRIOR TO A URETORENOSCOPY PROCEDURE, ONE PIGTAIL OF A UNIVERSA SOFT URETERAL STENT WAS FOUND CRACKED. THE TETHER WAS STILL ATTACHED TO THE DEVICE. A NEW DEVICE OF THE SAME PRODUCT REFERENCE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTIES. 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 12816504 ↗
• MalfunctionOct 26, 2021Material Separation; Material Separation

  AS REPORTED, UPON OPENING A UNIVERSA SOFT URETERAL STENT SET, THE STENT WAS BROKEN BETWEEN THE TWO SIDE PORTS ON ONE END. THE TETHER WAS ALSO ATTACHED TO THE STENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES REQUIRED DUE TO THE 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 12700688 ↗
• MalfunctionFeb 4, 2020Crack; Crack

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664201 ↗
• MalfunctionJan 30, 2020Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646522 ↗
• MalfunctionSep 18, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE LAST REPORT WAS SUBMITTED ON 18SEP2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9083704 ↗
• MalfunctionAug 23, 2019Fracture; Fracture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT ON 23AUG2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925628 ↗
• MalfunctionApr 10, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  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 8500976 ↗
• MalfunctionMar 6, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  NO NEW EVENT INFORMATION HAS BEEN PROVIDED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394389 ↗
• MalfunctionJan 17, 2019Break; Break

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257811 ↗
• MalfunctionNov 15, 2018Fracture; Fracture

  IT WAS REPORTED, DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE, THE PHYSICIAN IMPLANTED A UNIVERSA SOFT URETERAL STENT AND DISCOVERED THE PORTION OF THE STENT IN THE BLADDER WAS CRACKED. THE CRACKED STENT WAS DISCOVERED WITH A CYSTOSCOPE AFTER IT WAS IMPLANTED IT INTO PATIENT¿S URETER. A SECOND UNIVERSA SOFT URETERAL STENT WAS PLACED AND THEY DISCOVERED THAT STENT WAS CRACKED. THEY USED A COMPETITOR'S STENT TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074340 ↗
• MalfunctionNov 15, 2018Fracture; Fracture

  IT WAS REPORTED, DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE, THE PHYSICIAN IMPLANTED A UNIVERSA SOFT URETERAL STENT AND DISCOVERED THE PORTION OF THE STENT IN THE BLADDER WAS CRACKED. THE CRACKED STENT WAS DISCOVERED WITH A CYSTOSCOPE AFTER IT WAS IMPLANTED IT INTO PATIENT¿S URETER. THE PHYSICIAN LEFT THE STENT INSIDE THE PATIENT¿S URETER AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073693 ↗
• MalfunctionSep 4, 2018Crack; Crack

  IT WAS REPORTED, UPON OPENING TWO UNIVERSA SOFT URETERAL STENT SETS, CRACKS WERE SEEN ON THE PIGTAIL PART OF THE STENTS. ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT. THEY REPLACED CRACKED STENTS WITH NEW PRODUCT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841861 ↗
• MalfunctionApr 11, 2018Structural Problem; Split; Positioning Problem

  IT WAS REPORTED THAT THE URETERAL STENT HAD A SPLIT ON ITS DISTAL SIDE CAUSING THE GUIDE TO COME OUT THROUGH THE HOLE. AN ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7423166 ↗
• MalfunctionApr 11, 2018Break

  IT WAS REPORTED THAT THE PHYSICIAN TRIED TO PLACE THE UNIVERSA SOFT URETERAL STENT IN THE PATIENT'S URETER AND THE PIGTAIL WAS BROKEN BEFORE ENTRANCE INTO PATIENT'S BODY. A NEW UNIVERSA SOFT URETERAL STENT SET WAS USED TO FINISH THE URETEROSCOPY PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT OR END USER AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7421777 ↗