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Terminated

Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

FDA Recall Z-0869-2020 · Posted None

Recalling FirmLivaNova USA Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2018-11-16
Date Terminated2022-12-12
Product Quantity745 devices

Reason for Recall

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

Firm Action

The recalling firm issued Dear Doctor letters dated 11/16/2018 explaining the reason for the voluntary correction and pointing out a correction was previously initiated in June, 2017, related to this issue for devices distributed prior to October, 2015.

Root Cause

Manufacturing material removal

Distribution Pattern

Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.

Official Source

View FDA Recall →

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

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