Z-0750-2013Class II

Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable...

Name: Z-0750-2013 Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable...
Creator: Envoy Medical Corporation
Published: 2013-01-09
License: https://open.fda.gov/license/

Envoy Medical Corporation / initiated 2013-01-09 / Terminated / root cause: software

FDA source

Envoy Medical Corporation began a recall of 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... on 2013-01-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0750-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-09
Posted: 2013-01-30
Terminated: 2013-04-09
Recalling firm: Envoy Medical Corporation
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.
Product code: OAF Implant, Hearing, Active, Middle Ear, Totally Implanted
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0750-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0750-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-30

Product code OAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)