Cyberonics, Inc: Medical Device Recall in 2018 - (Recall #: Z-0555-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

Product Classification:

Class II

Date Initiated: December 2, 2017

Date Posted: February 14, 2018

Recall Number: Z-0555-2018

Event ID: 78914

Reason for Recall:

Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.

Status: Terminated

Product Quantity: 2 units

Code Information:

Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500

Distribution Pattern:

US Distribution to the states of : CO and ND

Voluntary or Mandated:

Voluntary: Firm initiated