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

FDA device recall Z-0659-2016 · posted 2016-01-15 · Terminated

Recall details

Recalling firm

Cyberonics, Inc

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.

Action taken

The firm notified consignees of the issue via letter on 12/18/15. The letter identified the affected device, the issue involved, and actions to be taken. Physicians are to contact Clinical Technical Support at 866-882-8804 to report if a patient's generator has been disabled due to the issue identified. Users are to complete and return the effectiveness card as soon as possible. If further information is needed, customers can contact Clinical Technical Support at 866-882-8804 or via e-mail at cservices@livanova.com.

Root cause

Device Design

Status

Terminated

Product code

LYJ

Quantity affected

4,935 units

Distribution

Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United

Date initiated

2015-12-18

Date posted

2016-01-15

Date terminated

2017-03-02

Location

Houston, TX