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Terminated

VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software

FDA Recall Z-1591-2010 · Posted 2010-05-10

Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2010-04-06
Date Terminated2012-08-20
Product QuantityModel103: 8109 units; Model 104: 1722 units; Programmers: 8891

Reason for Recall

Battery life projection is inaccurate.

Firm Action

Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic. The issue can also be corrected during the initial implant procedure with the instructions provided. Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.

Root Cause

Software design

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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