Envoy Medical Corporation: Medical Device Recall in 2013 - (Recall #: Z-0750-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 9, 2013

Date Posted: February 6, 2013

Recall Number: Z-0750-2013

Event ID: 63875

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.

Status: Terminated

Product Quantity: 44

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated