N/A (REF 401450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841898114304), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS DEVICE WAS REPORTEDLY IN USE DOWN THE ESOPHAGUS DURING AN EP PROCEDURE. DURING THIS TIME, THE TIP PROTECTOR WAS NOT TAKEN OFF OF THE CATHETER AND WAS LODGED DOWN THE PATIENT'S THROAT. THE PATIENT WAS TAKEN BACK TO THE RECOVERY ROOM, WHERE THEY WERE ABLE TO COUGH UP THE LODGED TIP PROTECTOR.

  Patient problems: Cough

  MAUDE report 12779456 ↗