Events

Recall of Device Recall Esteem Programmers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Envoy Medical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63875
  • Event Risk Class
    Class 2
  • Event Number
    Z-0750-2013
  • Event Initiated Date
    2013-01-09
  • Event Date Posted
    2013-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114942
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, hearing, active, middle ear, totally implanted - Product Code OAF
  • Reason
    Envoy medical is conducting a voluntary correction of a limited number of esteem programmers, part of the esteem totally implantable hearing system, to reduce their susceptibility to noise interference.
  • Action
    Envoy Medical Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-233-1204 for questions relating to this notice.

Device

Device Recall Esteem Programmers
  • Model / Serial
    Lot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053   Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510   Lot# EMC0004304 EMC0004797    Lot# EMC0003827 EMC0004233
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.
  • Product Description
    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. || The ISA and Commander are software packages that run on a laptop personal computer.
  • Manufacturer
    Envoy Medical Corporation

Manufacturer

Envoy Medical Corporation
  • Manufacturer Address
    Envoy Medical Corporation, 5000 Township Parkway, Saint Paul MN 55110
  • Manufacturer Parent Company (2017)
    Envoy Medical Corporation
  • Source
    USFDA