Medline URO180816SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942767038), received between Dec 4, 2019 and Dec 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• MalfunctionDec 30, 2021Material Rupture

  IT WAS REPORTED THAT THE INDWELLING (B)(6) CATHETER BALLOON DEFLATED WHILE INSERTED IN THE PATIENT. THE CATHETER FELL OUT OF THE PATIENT AND WAS REPLACED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118080 ↗
• MalfunctionDec 4, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT A FOLEY CATHETER EXCHANGE WAS REQUIRED AFTER FOLEY CATHETER WAS FOUND DISCONNECTED WITH THE DRAINAGE BAG TUBING, WITH THE TAMPER SEAL STILL INTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9412573 ↗