Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0659-2016 — VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

U.S. FDA — Device Enforcement · United States · 2015-12-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0659-2016
Date of alert
2015-12-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cyberonics, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05425025750061
Reported risk: Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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