Universa G49877Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002498778), received between Jul 6, 2016 and Dec 4, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 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 23717738 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT ONE END OF A STENT FROM A UNIVERSA FIRM URETERAL STENT SET WAS FRACTURED. DURING AN INSERTION OF THE URETERAL STENT PROCEDURE, THE USER NOTED ONE END OF THE STENT HAD A FRACTURE PRIOR TO USE. ANOTHER SIMILAR-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23336530 ↗
• MalfunctionNov 1, 2019Break; Break

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 01NOV2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266412 ↗
• MalfunctionAug 27, 2019Defective Device; Defective Device

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935999 ↗
• MalfunctionMar 20, 2017Knotted; Knotted

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A CYSTOSCOPY WITH REMOVAL OF A STENT FROM THE BLADDER. A UNIVERSA FIRM URETERAL STENT WAS BEING REMOVED. DURING THE REMOVAL OF THE STENT IT WAS DISCOVERED VIA X-RAY THAT THERE WAS A KNOT IN THE STENT. THE STENT WAS REMOVED SUCCESSFULLY WITHOUT ANY EXTRA PROCEDURES. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6417382 ↗
• InjuryFeb 10, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN ANTEGRADE URETIC STENT PLACEMENT VIA ACCESS FROM THE KIDNEY. A UNIVERSAL FIRM URETERAL STENT SET WAS USED. THE ATTENDING PHYSICIAN INDICATED THAT DURING THE REMOVAL OF THE AMPLATZ WIRE, IT GOT STUCK IN THE STENT AND COULD NOT BE REMOVED. THE TWO PHYSICIANS HAD TO REMOVE THE STENT AND WIRE TOGETHER OUT OF THE PATIENT AS ONE UNIT. THE WIRE WAS THEN SEPARATED AND REMOVED AND A NEW STENT WAS DEPLOYED. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADDITIONAL PROCEDURES OR ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6321600 ↗
• MalfunctionJul 6, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING INSERTION OF STENT INTO URETER/KIDNEY VIA BLADDER, THE STENT WAS PLACED OVER THE WIRE AS PER NORMAL AND AS THE WIRE WAS COMING OUT THE OTHER END A CURLED PIECE OF GREEN PLASTIC CAME OUT OF THE LUMEN OF THE STENT. THIS PIECE OF PLASTIC HAD BEEN INSIDE THE STENT AND WAS PUSHED OUT BY THE WIRE EXTERNAL TO THE PATIENT. AFTER THIS, THE POSITIONER WAS THEN PUT OVER THE WIRE AND THE STENT WAS PLACED AS PER USUAL. ONLY THE STENT WAS LEFT INSIDE THE PATIENT AS PER NORMAL AND NO ADDITIONAL PROCEDURES OR EQUIPMENT WAS REQUIRED. A PART FROM THE SUCCESSFULLY DEPLOYED STENT, NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. ACCORDING TO THE INITIAL REPORTER , THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5772709 ↗