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Terminated

VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

FDA Recall Z-1526-2015 · Posted 2015-04-27

Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2015-03-06
Date Terminated2015-10-09
Product Quantity13 units

Reason for Recall

The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.

Firm Action

On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.

Root Cause

Nonconforming Material/Component

Distribution Pattern

AR, TX, GA, CA, MI, IN, FL, AZ, NV

Official Source

View FDA Recall →

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

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