Universa G49945Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002499454), received between Nov 3, 2016 and Apr 30, 2026 — classified as 2 injuries, 13 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT ONE END OF THE STENT FROM A UNIVERSA SOFT URETERAL STENT SET WAS FOUND TO BE SEPARATED AS THE NURSE WAS PREPARING THE DEVICE FOR A URETERAL STENT REPLACEMENT PROCEDURE. A NEW SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046671 ↗
• MalfunctionDec 16, 2022Material Separation; Material Separation

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, AN UNIVERSA SOFT URETERAL STENT SET PASSED THROUGH THE GUIDE DURING INSERTION AND A TEAR WAS OBSERVED IN THE DISTAL PART OF THE CATHETER, PREVENTING ITS PASSAGE. ANOTHER CATHETER OF THE SAME TYPE 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 AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997199 ↗
• MalfunctionAug 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN A UNIVERSA SOFT URETERAL STENT SET WAS OPENED, THE USER NOTED THE STENT HAD A TEAR ON THE UNTETHERED END. THE TETHER WAS ATTACHED TO THE STENT WHEN THE SET WAS OPENED. THE USER COMPLETED THE PROCEDURE WITH A NEW DEVICE OF THE SAME PRODUCT REFERENCE. 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 15294227 ↗
• MalfunctionMar 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 9852886 ↗
• MalfunctionSep 12, 2019Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED ON 18SEP2019: THE EXTRAVASATION WAS CAUSED BY A LASER INJURY TO THE URETER WHILE ATTEMPTING TO BREAK KNOTS IN THE STENT, AND THE CONTRAST WAS LEAKING FROM THE URETERIC WALL. THE PATIENT SHOWED NO EVIDENCE OF INFECTION BUT WAS GIVEN ORAL ANTIBIOTICS FOR PROPHYLACTIC. THERE WAS 200ML OF BLOOD LOSS NOTED AFTER THE KNOTTED STENT WAS REMOVED.

  Patient problems: No Code Available

  MAUDE report 9013899 ↗
• MalfunctionMar 4, 2019Break; Break

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386243 ↗
• MalfunctionSep 25, 2018Material Split, Cut or Torn

  IT WAS INITIALLY REPORTED, THE DOUBLE J CATHETER TORN IN THE DISTAL PART. A NEW ONE IS REQUEST. AFTER FOLLOW UP, ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER ON (B)(6) 2018. AS REPORTED, YES, IT WAS NECESSARY TO USE A NEW CATHETER TO COMPLETE THE PROCEDURE. AT THE MOMENT OF PASSING THE GUIDE, RUPTURE OF THE DISTAL PART OF THE CATHETER WAS GENERATED AT THE BEGINNING OF THE PROCEDURE. FOR THIS REASON IT WAS NECESSARY TO USE A NEW CATHETER. A NEW CATHETER OR DOUBLE STENT J UNIVERSA WAS USED. IT WAS NOT NECESSARY TO REMOVE ANY ELEMENT FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905153 ↗
• MalfunctionApr 13, 2018Break; Cut In Material

  IT WAS REPORTED THAT THE UNIVERSA SOFT URETERAL STENT BROKE IN HALF UPON AN ATTEMPT TO ELONGATE THE DEVICE AND CUT THE THREADS OFF. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT AND THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428274 ↗
• MalfunctionApr 12, 2018Fracture; Torn Material

  IT WAS REPORTED THAT THERE WAS A FRACTURE AT THE END OF THE CATHETER. IT WAS FURTHER NOTED THAT THE END OF THE URETERAL STENT WAS TORN. THE CUSTOMER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426031 ↗
• MalfunctionJan 9, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT UPON REMOVAL FROM THE STERILE PACKAGE, THEY NOTICED THAT A STENT FROM A UNIVERSA SOFT URETERAL STENT SET WAS SPLIT. THE STENT WAS NOT USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7175011 ↗
• MalfunctionNov 10, 2017Split; Split

  THE AREA REPRESENTATIVE REPORTED DURING INSERTION OF THE UNIVERSA SOFT URETERAL STENT, UPON PASSING THE STENT OVER WIRE, A SPLIT IN THE DISTAL END OF THE STENT WAS NOTICED. THE STENT WAS REMOVED AND ANOTHER STENT OPENED AND USED WITHOUT INCIDENT. 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 7022973 ↗
• InjuryNov 7, 2017Knotted; Knotted

  THE AREA REPRESENTATIVE REPORTED THE DOCTOR TWO (2) UNIVERSA SOFT URETERAL STENTS IN A (B)(6)-OLD, MALE PATIENT 3 MONTHS AGO. THE STENTS WERE BOTH ENCRUSTED. ON (B)(6) 2017 THE DOCTOR MANAGED TO REMOVE THE RIGHT STENT, BUT THE LEFT STENT KNOTTED DURING THE REMOVAL PROCESS. THE DOCTOR SENT THE PATIENT FOR EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) IN AN ATTEMPT TO SPRING THE KNOT LOOSE, BUT IT FAILED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND DUE TO RETURN ON (B)(6) 2017 IN ATTEMPT TO REMOVE THE KNOTTED STENT. THE DOCTOR ASKED FOR ADVICE AND IF THE MANUFACTURER HAD ANY SUGGESTIONS ON THIS CASE. ON (B)(6) 2017, A CYSTOSCOPY WAS PERFORMED THREADING A WIRE TO STRAIGHTEN THE UPPER PIGTAIL. THIS ATTEMPT FAILED. THE PATIENT WAS LEFT IN PAIN AS THE DISTAL END OF THE STENT REMAINED SOMEWHERE IN THE PATIENT¿S PENILE SHAFT. A SECOND CYSTOSCOPY WAS PERFORMED AND THE DOCTOR MANAGED TO PULL THE KNOTTED STENT OUT USING AN AMPLATZ SUPERSTIFF WIRE WITH THE PATIENT UNDER HEAVY SEDATION. AS REPORTED, THE PATIENT IS WELL BUT IS UNDER CLOSE OBSERVATION.

  Patient problems: Pain

  MAUDE report 7005570 ↗
• MalfunctionAug 29, 2017Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  THE DEVICE END WAS BROKEN: SPLIT ON PIGTAIL. THE CATHETER HAD NO CONTACT WITH THE PATIENT.

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

  MAUDE report 6828868 ↗
• MalfunctionMay 23, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT THE TIP OF THE WIRE GUIDE OF A UNIVERSA SOFT URETERAL STENT SET WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

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

  MAUDE report 6584891 ↗
• InjuryNov 3, 2016Break; Break

  IT WAS REPORTED A SCRUB NURSE NOTICED THE END OF THE STENT PUSHER WAS MISSING AFTER A URETEROSCOPY PROCEDURE AND NOTIFIED THE SURGEON. AN X-RAY WAS TAKEN WHICH IDENTIFIED THE STENT PUSHER FRAGMENT AS A SMALL RADIO-OPAQUE OBJECT, APPROXIMATELY 2X4MM, IN THE RENAL PELVIS OF THE PATIENT. THE DOCTOR REPORTED THEY WERE IN A POSITION TO REPEAT THE URETEROSCOPY AND WERE ABLE TO SUCCESSFULLY RETRIEVE THE PART WITH A STONE BASKET. THE DOCTOR ADDITIONALLY REPORTED ¿ IF WE HADN'T, IT IS LIKELY THAT IT WOULD HAVE PASSED SPONTANEOUSLY, PERHAPS WITH TRANSIENT OBSTRUCTION.¿ A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6075210 ↗