Z-0868-2020 Class II Terminated
FDA device recall Z-0868-2020 was initiated by LivaNova USA Inc on Nov 16, 2018 and is designated Class II. 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… The recall status is terminated (terminated Dec 12, 2022). Affected quantity: 106 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 5, 2020
- Initiation Date
- Nov 16, 2018
- Termination Date
- Dec 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 devices
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.
Distribution Pattern
Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
Code Information
Serial numbers 35794, 37762, 37792, 37872, 37874, 37881, 37885, 37889, 37890, 37893, 37913, 37915, 37916, 37965, 37975, 37977, 37984, 37987, 37988, 37990, 38051, 38054, 38068, 38132, 38148, 38153, 38154, 38155, 38162, 38173, 38210, 38224, 38226, 38239, 38240, 38243, 38245, 38246, 38248, 38249, 38252, 38268, 38272, 38273, 38274, 38275, 38277, 38279, 38282, 38284, 38292, 38293, 38296, 38299, 38302, 38306, 38308, 38312, 38314, 38315, 38319, 38321, 38326, 38330, 38344, 38443, 38464, 38490, 38505, 38517, 38529, 38530, 38549, 38561, 38564, 38565, 38625, 38628, 38651, 38661, 38689, 38691, 38698, 38702, 38719, 38722, 38730, 38735, 38745, 38751, 38754, 38755, 38771, 38773, 38775, 38779, 38800, 38804, 38805, 38809, 39334, 39344, 39347, 39354, 39362, and 39731. The expiration date range is 2/25/2017-5/1/2017.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0868-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026