Esteem Programmer Model 6001, US and ISA, Model 3001 Dell… recallZ-0750-2013 · Envoy Medical Corporation · initiated Jan 9, 2013
Class II Terminated All recalls posted in January 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Envoy Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0750-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 9, 2013
- Posted by the FDA
- Jan 30, 2013
- Recalling firm
- Envoy Medical Corporation
- Quantity
- 44
- Product code
- OAF
- FDA submissions
- P090018
- 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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under P090018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Esteem® Sound Processor 2001Envoy Medical Corporation · Implant, Hearing, Active, Middle Ear, Totally Implanted2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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