Home / Recalls / Cyberonics, Inc / Z-0645-2016

Z-0645-2016 Class II Terminated

Recalled by Cyberonics, Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
January 27, 2016
Initiation Date
November 18, 2015
Termination Date
September 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29 units

Product Description

Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

Reason for Recall

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

Distribution Pattern

US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.

Code Information

Serial numbers 36602, 37019, 39097, 40311, 40465

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-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)