JOURNEY 71422381Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010626851), received between Jun 29, 2018 and Oct 22, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionOct 22, 2020Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT A JOURNEY UNI TRAY 3 T IS WORN AND PROTECTIVE MATERIAL IS CHIPPING OFF. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, WHEN IT OCCURRED, AND HOW WAS THE PROCEDURE WAS FINISHED. IT IS ALSO UNKNOWN IF THERE WAS ANY HARM OR INJURY ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10718447 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, WHEN OPENING THE INSTRUMENTS TRAYS; FROM 3 TRAYS THAT THE SURGEON HAD AVAILABLE, 1 WAS MISSING; CAUSING A DELAY GREATER THAN 30 MINUTES AND FORCING THE SURGEON TO CHANGE THE ORIGINAL PROCEDURE TO CONTINUE WITH THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652321 ↗