Recall Z-0868-2020— LivaNova USA Inc

Name: FDA recall Z-0868-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-16

Class II · Terminated

Class II FDA medical device recall by LivaNova USA Inc, initiated 2018-11-16, terminated 2022-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.. Reason: 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..

Recalling firm: LivaNova USA Inc
Classification: Class II
Status: Terminated
Initiated: 2018-11-16
Terminated: 2022-12-12
Firm location: Houston, TX, United States

Product description

Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.