VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming Sy
FDA device recall Z-1591-2010 · posted 2010-05-10 · Terminated
Recall details
- Recalling firm
- Cyberonics, Inc
- Reason for recall
- Battery life projection is inaccurate.
- Action taken
- 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
- Status
- Terminated
- Product code
- LYJ
- Quantity affected
- Model103: 8109 units; Model 104: 1722 units; Programmers: 8891
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-04-06
- Date posted
- 2010-05-10
- Date terminated
- 2012-08-20
- Location
- Houston, TX
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