CRADLE MAJ-2032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170328381), received between Jun 21, 2023 and Jun 21, 2023 — classified as 2 injuries.

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.

• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PATIENT SWALLOWED THE CRADLE ENDO CAPSULE AND INFORMED THE STAFF THEY HAVE A PACEMAKER. THE PATIENT WAS MONITORED FOR ONE HOUR AND SENT HOME WITH THE INSTRUCTION TO MONITOR. THE STUDY WAS COMPLETED AND RESULTS WERE OBTAINED WITHOUT ANY PROBLEMS, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17176562 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PATIENT SWALLOWED THE CRADLE ENDO CAPSULE AND INFORMED THE STAFF THEY HAVE A PACEMAKER. THE PATIENT WAS MONITORED FOR ONE HOUR AND SENT HOME WITH THE INSTRUCTION TO MONITOR. THE STUDY WAS COMPLETED AND RESULTS WERE OBTAINED WITHOUT ANY PROBLEMS, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17176411 ↗