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Universa G23399Recalls & reported problems

Cook Incorporated · Universa Firm Ureteral Stent and Positioner With Hydrophilic Coating and Monofilament Tether · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002233994), received between May 14, 2019 and May 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Calcified” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Calcified1
  • Material Separation1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Code Available1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED, A PATIENT HAD A UNIVERSA FIRM URETERAL STENT PLACED (B)(6) 2019. ON (B)(6) 2019, THE PHYSICIAN ATTEMPTED REMOVAL OF THE STENT WITH FLEXIBLE CYSTOSCOPY AND LOCAL ANESTHESIA AND WAS UNSUCCESSFUL. LATER THAT SAME DAY, THE PATIENT UNDERWENT GENERAL ANESTHESIA LASER REMOVAL OF ENCRUSTED STENT. THE STENT WAS REMOVED AFTER AN EXTENDED PERIOD OF TIME. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Code Available

    MAUDE report 8610071 ↗
  • InjuryMay 14, 2019Calcified; Material Separation; Calcified; Material Separation

    IT WAS INITIALLY REPORTED ON 12APR2019, THE CUSTOMER HAS RECENTLY NOTICED SEVERE ENCRUSTATIONS OCCURRING ON THE UFH STENTS AND REMOVAL ISSUES. THEY HAD NOT RETAINED ANY DEVICES FOR INVESTIGATION. CUSTOMER WAS ASKED TO PLEASE RETAIN STENTS FOR ANALYSIS IF ISSUE OCCURS. ADDITIONAL INFORMATION WAS PROVIDED ON 19APR2019. THE COATING OF THE DEVICE WAS ACTIVATED WITH SALINE, ALTHOUGH IT IS UNKNOWN HOW LONG IT WAS ACTIVATED. THE DEVICE WAS ACCESSED THROUGH THE URETERIC ORIFICE. THE PATIENT HAS BEEN DIAGNOSED AS BEING A STONE FORMER, HAVING THE PRE-EXISTING CONDITION OF RENAL CALCULI. THE DEVICE WAS REMOVED, THEN REPLACED WITH DIFFICULTY. THERE ARE NO PHOTOS, IMAGES, OR VIDEOS AVAILABLE, NOR PATHOLOGY REPORTS. IT IS UNKNOWN IF ANY INTERVENTION, ADDITIONAL PROCEDURES, AND/OR MEDICATIONS HAVE BEEN ADMINISTERED. NEW INFORMATION WAS RECEIVED ON 29APR2019: ON (B)(6) 2019, PERFORMED PLANNED PROCEDURE AND THE UNIVERSA FIRM URETERAL STENT WAS INSERTED. ON (B)(6) 2019, PATIENT RETURNED FOR PLANNED PROCEDURE AND IT WAS NOTED THAT THE STENT WAS ENCRUSTED. TRIED TO REMOVE IT, BUT WAS ONLY ABLE TO REMOVE THE BOTTOM END. NEPHROSTOMY TUBE WAS REQUIRED AND INSERTED ON (B)(6) 2019. BASED ON THE INFORMATION

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8609343 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

Sources and updates

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