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.
Reported: February 5, 2020 Initiated: November 16, 2018 #Z-0869-2020
Product Description
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.
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.
Details
- Recalling Firm
- LivaNova USA Inc
- Units Affected
- 745 devices
- Distribution
- Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by LivaNova USA Inc. Units affected: 745 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2020. Severity: Moderate. Recall number: Z-0869-2020.
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