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Terminated

Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.

FDA Recall Z-0995-2009 · Posted 2009-04-22

Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2008-02-07
Date Terminated2011-02-28
Product Quantity108 units.

Reason for Recall

Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.

Firm Action

Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered). Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician. If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.

Official Source

View FDA Recall →

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

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