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Terminated

Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

FDA Recall Z-0645-2016 · Posted 2016-01-13

Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2015-11-18
Date Terminated2017-09-06
Product Quantity29 units

Reason for Recall

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

Firm Action

Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804

Root Cause

Manufacturing material removal

Distribution Pattern

US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.

Official Source

View FDA Recall →

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

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