Date Initiated by Firm |
August 13, 2019 |
Create Date |
February 10, 2020 |
Recall Status1 |
Terminated 3 on May 18, 2022 |
Recall Number |
Z-1118-2020 |
Recall Event ID |
84710 |
PMA Number |
P970003 |
Product Classification |
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
|
Product |
VNS Therapy SENTIVA Generator Model # 1000
Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
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Code Information |
Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102 Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102 Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102 Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102 Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102 Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102 |
Recalling Firm/ Manufacturer |
LivaNova USA Inc 100 Cyberonics Blvd Houston TX 77058-2069
|
For Additional Information Contact |
Njemile Crawley 281-228-7575
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Manufacturer Reason for Recall |
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
|
FDA Determined Cause 2 |
Process control |
Action |
On 08/13/2019, the firm contacted via telephone hospitals/facilities of the immediate need to remove and replace the affected devices. Reference Firm email communication dated 1/27/2020.
On 08/30/2019, prescribing physicians were telephone call with a follow-up email recommending replacement of the generators during an already planned or unrelated lead replacement surgery. |
Quantity in Commerce |
6 generators |
Distribution |
US: FL, GA, KS, MO, and UT.
No OUS distribution |
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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