Medline URO180714Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942687077), received between Jul 7, 2020 and May 22, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryMay 22, 2023Break; Break

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 A PATIENT CALLED AFTER A SURGICAL PROCEDURE THAT REQUIRED A FOLEY INSERTION, TO REPORT THAT WHEN SHE URINATED SHE PULLED A "1.5 TO 2 INCH PIECE OF PLASTIC FROM HER URETHRA".

  Patient problems: Foreign Body In Patient

  MAUDE report 16974119 ↗
• InjuryJul 7, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT WITH AN INDWELLING CATHETER INSERTED PULLED ON THE CATHETER AND BROKE THE CATHETER OFF BELOW THE NECK OF THE BALLOON WHILE STILL INSERTED REQUIRING SURGICAL REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10242234 ↗