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U.S. Department of Health and Human Services

Class 2 Device Recall Esteem Programmers

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  Class 2 Device Recall Esteem Programmers see related information
Date Initiated by Firm January 09, 2013
Date Posted January 30, 2013
Recall Status1 Terminated 3 on April 09, 2013
Recall Number Z-0750-2013
Recall Event ID 63875
PMA Number P090018 
Product Classification Implant, hearing, active, middle ear, totally implanted - Product Code OAF
Product 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.
Code Information 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
Recalling Firm/
Envoy Medical Corporation
5000 Township Parkway
Saint Paul MN 55110
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 44
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OAF and Original Applicant = ENVOY MEDICAL CORPORATION