VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therap

FDA device recall Z-0642-2010 · posted 2010-01-14 · Terminated

Recall details

Recalling firm

Cyberonics, Inc

Reason for recall

Under certain conditions, product's battery life can be reduced.

Action taken

Firm sent "An Important Safety Notice" letter to all physicians explaining events, risks presented and recommended actions. Letter was mailed November 20, 2009. Physicians should complete and return the effectiveness card as soon as possible to acknowledge that you have read and understood the Safety Alert Letter. If further information is needed, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.

Root cause

Other

Status

Terminated

Product code

LYJ

Quantity affected

8,667 units

Distribution

Worldwide Distribution -- USA, Argentina, Austria, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Iceland, Israel, Italy, Kuwait, L

Date initiated

2009-11-20

Date posted

2010-01-14

Date terminated

2012-07-24

Location

Houston, TX