Infinity 00711499Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816765012185), received between May 4, 2018 and Jun 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 14, 2018Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE DISTAL BRUSH HEAD BECAME DETACHED FROM THE INFINITY CYTOLOGY BRUSH DEVICE. THE BRUSH HEAD WAS IMMEDIATELY RETRIEVED WITH NO REPORT OF PATIENT HARM DUE TO THE DETACHED COMPONENT NOR THE RETRIEVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602839 ↗
• MalfunctionMay 4, 2018Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING AN EGD PROCEDURE, THE DISTAL BRUSH HEAD BECAME DETACHED FROM THE INFINITY CYTOLOGY BRUSH DEVICE. THE BRUSH HEAD WAS IMMEDIATELY RETRIEVED WITH NO REPORT OF PATIENT HARM DUE TO THE DETACHED COMPONENT NOR THE RETRIEVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7488096 ↗