Company:Cyberonics, Inc.
Date of Enforcement Report 12/9/2009
Class:ll

PRODUCT
Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010

REASON
Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report “Lead Impedance: OK” when a short-circuit condition exists that prevents the lead from delivering therapy to the vagus nerve.

RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on July 24, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9,500 programming devices

DISTRIBUTION
Nationwide, 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