Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 2

FDA device recall Z-0264-2010 · posted 2009-11-16 · Terminated

Recall details

Recalling firm

Cyberonics, Inc

Reason for recall

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.

Action taken

Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take. Labeling updates are being developed concurrently with the notification. The firm will mail or hand-deliver the notifications via firm representatives.

Root cause

Device Design

Status

Terminated

Product code

LYJ

Quantity affected

9,500 programming devices

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, Hung

Date initiated

2009-07-24

Date posted

2009-11-16

Date terminated

2012-09-26

Location

Houston, TX