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Class 2 Device Recall Cyberonics VNS Therapy AspireHC Model 105 Generator |
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Date Initiated by Firm |
November 16, 2018 |
Create Date |
January 27, 2020 |
Recall Status1 |
Terminated 3 on December 12, 2022 |
Recall Number |
Z-0868-2020 |
Recall Event ID |
84029 |
PMA Number |
P970003 |
Product Classification |
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
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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. |
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. |
Recalling Firm/ Manufacturer |
LivaNova USA Inc 100 Cyberonics Blvd Houston TX 77058-2069
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For Additional Information Contact |
Clinical Technical Services 866-882-8804
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Manufacturer 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.
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FDA Determined Cause 2 |
Manufacturing material removal |
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. |
Quantity in Commerce |
106 devices |
Distribution |
Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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