Device Recall Cyberonics

  • Model / Serial
    Serial #'s: 2181, 3427, 3902, 4082, 4083, 4116, 4129, 4132, 4158, 4177, 4185, 4204, 4235, 4304, 4351, 4495, 4591, 4610, 4621, 4716, 4728, 4737, 4823, 4834, 4855, 4904, 5105, 5165, 5220, 6039, 6046, 6121, 6124, 6234, 6343, 6513, 6552, 6625, 6674, 6680, 6682, 6700, 6715, 7662, 7738, 7875, 8008, 8163,8820, 8971, 9010, 9171, 9213, 9215, 9217, 9222, 9241, 9260, 9283, 9312, 9333, 9398, 9442, 9451, 9547, 9552, 12590, 12672, 18644, 21949, 22061, 22177, 22455, 22814, 23267, 23736, 25079, 25125, 25545, 25888, 26212, 26254, 26346, 26513, 26527, 26847, 26912, 26932, 27012, 27026, 27127, and 32232.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
  • Product Description
    VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. || Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial numbers 36602, 37019, 39097, 40311, 40465
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
  • Product Description
    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
  • Manufacturer
  • Model / Serial
    Serial #'s: 2220, 4966, 5035, 8816, 8830, 8878, 9476, 9478, 12422, 12533, 23423, 23460, and 25434.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
  • Product Description
    Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. || Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and 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.
  • Manufacturer
  • Model / Serial
    Model 250, VNS Therapy Programming M250 Programming System, version 4.6, 6.1, 7.0 or 7.1 labeling
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.
  • Manufacturer