Universa G17207Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002172074), received between Nov 28, 2018 and Jul 18, 2019 — classified as 3 malfunctions.

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

• MalfunctionJul 18, 2019Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION PROVIDED: THE PROCEDURE BEING PERFORMED WAS FOLEY CATHETER REPLACEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8804745 ↗
• MalfunctionJul 18, 2019Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION PROVIDED: THE PROCEDURE BEING PERFORMED WAS FOLEY CATHETER REPLACEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804068 ↗
• MalfunctionNov 28, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT UNIVERSAL SILICONE FOLEY CATHETER BALLOON WAS INFLATED WITH WATER AT 10CC, AFTER FEW DAYS IT REDUCED TO 3CC. THE DEVICE WAS REPLACED, BUT THERE WERE NO INJURIES BESIDE THE ADDITIONAL PROCEDURE FOR REPLACEMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Code Available

  MAUDE report 8110359 ↗