Home / Recalls / Cyberonics, Inc / Z-1526-2015

Z-1526-2015 Class II Terminated

Recalled by Cyberonics, Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
May 6, 2015
Initiation Date
March 6, 2015
Termination Date
October 9, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 units

Product Description

VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

Reason for Recall

The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.

Distribution Pattern

AR, TX, GA, CA, MI, IN, FL, AZ, NV

Code Information

Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715

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-3020-2017 Class II — VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 1 (June 13, 2017)
  • Z-3019-2017 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-0858-2015 Class II — Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy (November 20, 2014)