Home / Recalls / Cyberonics, Inc / Z-0659-2016

Z-0659-2016 Class II Terminated

Recalled by Cyberonics, Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
January 27, 2016
Initiation Date
December 18, 2015
Termination Date
March 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,935 units

Product Description

VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Reason for Recall

Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.

Distribution Pattern

Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.

Code Information

All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061

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-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)