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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 Posting Updated 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