Home / Recalls / Cyberonics, Inc / Z-0555-2018

Z-0555-2018 Class II Terminated

Recalled by Cyberonics, Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
February 14, 2018
Initiation Date
December 2, 2017
Termination Date
August 6, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

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.

Reason for Recall

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

Distribution Pattern

US Distribution to the states of : CO and ND

Code Information

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

Other recalls by Cyberonics, Inc

  • Z-2255-2018 Class II — VNS Therapy Programmer, Model 3000, v1.0 System (November 13, 2017)
  • Z-3019-2017 Class II — VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 1 (June 13, 2017)
  • Z-3020-2017 Class II — VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 1 (June 13, 2017)
  • Z-0659-2016 Class II — VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive (December 18, 2015)
  • Z-0645-2016 Class II — Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 (November 18, 2015)
  • Z-0280-2016 Class II — Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 (October 7, 2015)
  • Z-1526-2015 Class II — VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generato (March 6, 2015)
  • Z-0858-2015 Class II — Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy (November 20, 2014)