Universa G49973Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002499734), received between Mar 30, 2017 and Aug 23, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionAug 23, 2022Migration; Migration

  AS REPORTED, A UNIVERSA SOFT URETERAL STENT MIGRATED WHILE INDWELLING IN THE PATIENT. THE DEVICE WAS IMPLANTED (B)(6) 2015 AND WAS ABLE TO BE PLACED IN THE INTENDED LOCATION. THERE WAS NO MALFUNCTION OF THE DEVICE DURING THE PLACEMENT PROCEDURE. THE PATIENT DID NOT HAVE ANY MEDICAL PROBLEMS OR COMPLICATIONS RELATED TO THE DEVICE. THE DEVICE WAS REMOVED VIA CYSTOSCOPE (B)(6) 2015 AFTER HAVING MIGRATED. NO FURTHER TREATMENT OR ADDITIONAL STENT PLACEMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274554 ↗
• MalfunctionApr 11, 2018Device Damaged Prior to Use; Torn Material

  IT WAS REPORTED THAT THE UNIVERSAL SOFT URETERAL STENT WAS FOUND TO BE TORN UPON OPENING THE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WAS NO IMPACT TO THE PATIENT OR USERS.

  Patient problems: No Patient Involvement

  MAUDE report 7422795 ↗
• MalfunctionApr 11, 2018Torn Material

  THE COMPLAINANT REPORTED THAT THERE WAS A TEAR IN THE SIDE OF THE UNIVERSA SOFT URETERAL STENT UPON OPENING THE PACKAGE. THERE WAS NO REPORTED IMPACT TO THE PATIENT OR END USER AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421473 ↗
• MalfunctionJul 17, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT THE UNIVERSA SOFT URETERAL STENT SET WAS FOUND DAMAGED WHEN TESTED PRIOR TO PERFORMING AN UNSPECIFIED PROCEDURE. THE DAMAGE WAS NOT DESCRIBED FURTHER. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE CUSTOMER OPENED A NEW SET OF UNIVERSA SOFT URETERAL STENT TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION REQUESTED FROM THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 6716937 ↗
• MalfunctionMar 30, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN URETEROECOPY WITH LASER LITHROTIPSY PROCEDURE. THE DEVICE IN USE WAS THE UNIVERSAL SOFT URETERAL STENT SET. THE ATTENDING PHYSICIAN INDICATED THAT THE STENT BUCKLED DURING INSERTION AND THE STENT TORE WHEN THEY TRIED TO REMOVE THE TETHER. THE PHYSICIAN STATED A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 6445506 ↗