Home / Recalls / Cyberonics, Inc / Z-0858-2015

Z-0858-2015 Class II Terminated

Recalled by Cyberonics, Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
December 31, 2014
Initiation Date
November 20, 2014
Termination Date
February 8, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Reason for Recall

The recalled product was distributed with an incorrect serial number printed on the device's label.

Distribution Pattern

Distributed to PA.

Code Information

Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Other recalls by Cyberonics, Inc

  • Z-0555-2018 Class II — VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/I (December 2, 2017)
  • 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)