Universa G23407Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002234076), received between Apr 27, 2016 and Jan 24, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2020Migration; Migration

  ADDITIONAL INFORMATION RECEIVED ON 28JAN2020: THE STENT WAS INITIALLY PLACE ON (B)(6) 2019. THE STENT MIGRATED FROM THE BLADDER AND INTO THE DISTAL URETER. THE TETHER WAS REMOVED AT THE TIME THE STENT WAS PLACED. THE INITIAL PLAN WAS TO REMOVE THE STENT UNDER LOCAL ANESTHESIA, BUT WAS INSTEAD REMOVED UNDER GENERAL ANESTHESIA USING "ADVANCED INSTRUMENTS." THE ONLY UPDATE ON THE PATIENT CONDITION AVAILABLE IS THAT THE PATIENT IS "FEELING FINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9627356 ↗
• MalfunctionSep 14, 2017Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THE SCRUB TECH NOTICED THAT THE TAPERED END OF THE UNIVERSA FIRM URETERAL STENT WAS CRIMPED SHUT BEFORE USE. AS REPORTED, THIS DEVICE WAS NOT USED. THE DEVICE DID NOT MAKE PATIENT CONTACT.

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

  MAUDE report 6864941 ↗
• MalfunctionAug 10, 2017Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE USER FACILITY REPORTED DURING A URETEROSCOPY PROCEDURE AND PRIOR TO USE, THE UNIVERSA FIRM URETERAL STENT SET WAS FOUND TO NOT HAVE AN OPENING ON ONE END DUE TO THE OPENING WAS PINCHED. THIS DEVICE WAS NOT USED. AS REPORTED, NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS REPORTED DEVICE ISSUE. NO SECTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY AS THE DEVICE WAS NOT USED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS DEVICE ISSUE. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT FILING.

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

  MAUDE report 6783938 ↗
• MalfunctionAug 8, 2017Break

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, THE STENT WAS BEING PREPARED FOR USE WHEN THE TETHERS SNAPPED OFF. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6775125 ↗
• InjuryApr 27, 2016Material Separation; Material Separation

  DURING A BILATERAL STENT PLACEMENT, THE TETHER STRETCHED AND BROKE INSIDE THE PATIENT. THE TETHER WAS REMOVED FROM THE PATIENT USING A GRASPER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 Code Available

  MAUDE report 5610915 ↗