Universa G32764Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002327641), received between Apr 21, 2017 and Apr 21, 2017 — classified as 2 injuries.

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

• InjuryApr 21, 2017Migration or Expulsion of Device; Torn Material; Migration or Expulsion of Device; Torn Material

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A UNIVERSA SILICONE FOLEY CATHETER. THE REPORT INDICATED THAT THE PATIENT WAS SUFFERING FROM HAEMATURIA. ON (B)(6) 2017 A UNIVERSA SILICONE FOLEY CATHETER WAS IMPLANTED AT 10H00 AND BY 16H00 THE CATHETER WAS FOUND IN THE PATIENT¿S BED. THE BALLOON ¿CUT IN ITS LENGTH¿. LATER, AT 18H00 A NEW CATHETER IMPLANTED AND BY 20H30 THE CATHETER WAS FOUND IN THE PATIENT¿S BED ONCE AGAIN. THE BALLOON ¿CUT IN ITS LENGTH¿. FINALLY, ON THE MORNING OF (B)(6) 2017 AT 05H00 A NEW UNIVERSA SILICONE FOLEY CATHETER WAS IMPLANTED AND THE PATIENT¿S BLADDER WAS DISCOVERED TO BE SWOLLEN. BY 08H00 THE DEVICE WAS FOUND IN THE PATIENT¿S BED AND THE BALLOON ¿CUT IN ITS LENGTH¿. NO FURTHER INFORMATION WAS PROVIDED, ADDITIONALLY QUESTIONS HAVE BEEN SENT TO THE CUSTOMER FOR CLARIFICATION. THIS MEDWATCH IS FOR ONE OUT OF THREE UNIVERSA SILICONE FOLEY CATHETER IN QUESTION, REFERENCE MFR 1820334-2017-00845 FOR THIS COMPLAINT FILE. THE OTHER TWO REMAINING UNIVERSA SILICONE FOLEY CATHETER IN QUESTION; REFERENCE: 1820334-2017-00846 AND 1820334-2017-00847.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511339 ↗
• InjuryApr 21, 2017Migration or Expulsion of Device; Torn Material; Migration or Expulsion of Device; Torn Material

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A UNIVERSA SILICONE FOLEY CATHETER. THE REPORT INDICATED THAT THE PATIENT WAS SUFFERING FROM HAEMATURIA. ON (B)(6) 2017 A UNIVERSA SILICONE FOLEY CATHETER WAS IMPLANTED AT 10H00 AND BY 16H00 THE CATHETER WAS FOUND IN THE PATIENT¿S BED. THE BALLOON ¿CUT IN ITS LENGTH¿. LATER, AT 18H00 A NEW CATHETER IMPLANTED AND BY 20H30 THE CATHETER WAS FOUND IN THE PATIENT¿S BED ONCE AGAIN. THE BALLOON ¿CUT IN ITS LENGTH¿. FINALLY, ON THE MORNING OF (B)(6) 2017 AT 05H00 A NEW UNIVERSA SILICONE FOLEY CATHETER WAS IMPLANTED AND THE PATIENT¿S BLADDER WAS DISCOVERED TO BE SWOLLEN. BY 08H00 THE DEVICE WAS FOUND IN THE PATIENT¿S BED AND THE BALLOON ¿CUT IN ITS LENGTH¿. NO FURTHER INFORMATION WAS PROVIDED, ADDITIONALLY QUESTIONS HAVE BEEN SENT TO THE CUSTOMER FOR CLARIFICATION. THIS MEDWATCH IS FOR ONE OUT OF THREE UNIVERSA SILICONE FOLEY CATHETER IN QUESTION, REFERENCE 1820334-2017-00846 FOR THIS COMPLAINT FILE. THE OTHER TWO REMAINING UNIVERSA SILICONE FOLEY CATHETER IN QUESTION; REFERENCE: 1820334-2017-00847 AND 1820334-2017-00845.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511132 ↗