Miracle-Ear MEMINI RF 2 XP RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056839098707), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IN THIS EVENT, THE END USER WENT TO HIS HEALTH CARE PROVIDER ((B)(6) 2023) AND IT WAS DISCOVERED THAT THE DOME OF THE HA WAS STUCK IN HIS EAR AND HAD CAUSED AN INFECTION. PATIENT WAS UNAWARE AT THE TIME THAT DOME HAD BEEN STUCK IN EAR. USER WAS ADVISED BY THE HEALTH CARE PROVIDER TO GO TO URGENT CARE. PATIENT WENT TO HEALTH CARE PROVIDER FOR FOLLOW UP APPOINTMENT ((B)(6) 2023) AND HIS INFECTION HAS CLEARED UP; PATIENT IS FEELING BETTER. DEVICE WAS NOT RETURNED BY USER FOR INVESTIGATION. INVESTIGATORS TESTED 30 SAMPLES OF THE EAR TIP DOME AND EACH SAMPLE MET THE PULL TEST REQUIREMENTS (WITHSTAND 400G LOAD LONGER THAN 10 SECONDS WITHOUT FALLING OFF) INSTRUCTIONS FOR USE ARE ILLUSTRATED ON THE PRODUCT PACKAGING TO ENSURE PROPER INSERTION OF EARTIP 3.0 PRIOR TO USE. RECOMMEND USER TO FOLLOW THE USER GUIDE INSTRUCTION TO CHANGE THE EARTIP 3.0 REGULARLY TO AVOID ANY INCIDENT.

  Patient problems: Ear infection

  MAUDE report 18932872 ↗