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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy AspireSR Generator

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  Class 2 Device Recall VNS Therapy AspireSR Generator see related information
Date Initiated by Firm September 28, 2020
Create Date November 17, 2020
Recall Status1 Terminated 3 on November 02, 2022
Recall Number Z-0462-2021
Recall Event ID 86570
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy¿ AspireSR¿ Generator
Code Information Model Number: 106  Serial  Number UDI 1267031 010542502575006111191206172111182112670319910-0011-2101 1267050 010542502575006111191206172111182112670509910-0011-2101 1267039 010542502575006111191206172111182112670399910-0011-2101 1267030 010542502575006111191206172111182112670309910-0011-2101 1267025 010542502575006111191206172111182112670259910-0011-2101 1267028 010542502575006111191206172111182112670289910-0011-2101 1267047 010542502575006111191206172111182112670479910-0011-2101 1267020 010542502575006111191206172111182112670209910-0011-2101 1267003 010542502575006111191206172111182112670039910-0011-2101 1267049 010542502575006111191206172111182112670499910-0011-2101 1267037 010542502575006111191206172111182112670379910-0011-2101 1267033 010542502575006111191206172111182112670339910-0011-2101 1267027 010542502575006111191206172111182112670279910-0011-2101 1267001 010542502575006111191206172111182112670019910-0011-2101 1267054 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010542502575006111191210172111192112671639910-0011-2101 1267152 010542502575006111191210172111192112671529910-0011-2101 1267135 010542502575006111191210172111192112671359910-0011-2101 1267144 010542502575006111191210172111192112671449910-0011-2101 1267173 010542502575006111191210172111192112671739910-0011-2101 1267186 010542502575006111191210172111192112671869910-0011-2101 1267159 010542502575006111191210172111192112671599910-0011-2101 1267127 010542502575006111191210172111192112671279910-0011-2101 1267175 010542502575006111191210172111192112671759910-0011-2101 1267132 0105 42502575006111191210172111192112671329910-0011-2101 1267153 010542502575006111191210172111192112671539910-0011-2101 1267187 010542502575006111191210172111192112671879910-0011-2101 1267148 010542502575006111191210172111192112671489910-0011-2101 1267160 010542502575006111191210172111192112671609910-0011-2101 1267149 010542502575006111191210172111192112671499910-0011-2101 1267117 010542502575006111191210172111192112671179910-0011-2101 1267166 010542502575006111191210172111192112671669910-0011-2101 1267179 010542502575006111191210172111192112671799910-0011-2101 1267155 010542502575006111191210172111192112671559910-0011-2101 1267170 010542502575006111191210172111192112671709910-0011-2101 1267154 010542502575006111191210172111192112671549910-0011-2101 1267188 010542502575006111191210172111192112671889910-0011-2101 1267138 010542502575006111191210172111192112671389910-0011-2101 1267156 010542502575006111191210172111192112671569910-0011-2101 1267142 010542502575006111191211172111192112671429910-0011-2101 1267089 010542502575006111191211172111192112670899910-0011-2101 1267137 010542502575006111191211172111192112671379910-0011-2101 1267090 010542502575006111191207172111192112670909910-0011-2101 1267035 010542502575006111191207172111192112670359910-0011-2101 1267099 010542502575006111191207172111192112670999910-0011-2101 1267108 010542502575006111191207172111192112671089910-0011-2101 1267084 010542502575006111191207172111192112670849910-0011-2101 1267098 010542502575006111191207172111192112670989910-0011-2101 1267085 010542502575006111191207172111192112670859910-0011-2101 1267069 010542502575006111191207172111192112670699910-0011-2101 1267048 010542502575006111191207172111192112670489910-0011-2101 1267087 010542502575006111191207172111192112670879910-0011-2101 1267038 010542502575006111191207172111192112670389910-0011-2101 1267083 010542502575006111191207172111192112670839910-0011-2101 1267082 010542502575006111191207172111192112670829910-0011-2101 1267071 010542502575006111191207172111192112670719910-0011-2101 1267065 010542502575006111191207172111192112670659910-0011-2101 1267093 010542502575006111191207172111192112670939910-0011-2101 1267066 010542502575006111191207172111192112670669910-0011-2101 1267008 010542502575006111191207172111182112670089910-0011-2101 1267070 010542502575006111191207172111192112670709910-0011-2101 1267102 010542502575006111191207172111192112671029910-0011-2101 1267042 010542502575006111191207172111192112670429910-0011-2101 1267094 010542502575006111191207172111192112670949910-0011-2101 1267041 010542502575006111191207172111192112670419910-0011-2101 1267046 010542502575006111191207172111192112670469910-0011-2101 1267092 010542502575006111191207172111192112670929910-0011-2101 1267062 010542502575006111191207172111192112670629910-0011-2101 1267086 010542502575006111191207172111192112670869910-0011-2101 1267058 010542502575006111191207172111192112670589910-0011-2101 1267043 010542502575006111191207172111192112670439910-0011-2101 1267106 010542502575006111191207172111192112671069910-0011-2101 1267063 010542502575006111191207172111192112670639910-0011-2101 1267032 010542502575006111191207172111192112670329910-0011-2101 1267116 010542502575006111191207172111192112671169910-0011-2101 1267101 010542502575006111191207172111192112671019910-0011-2101 1267115 010542502575006111191207172111192112671159910-0011-2101 1267107 010542502575006111191207172111192112671079910-0011-2101 1267052 010542502575006111191207172111192112670529910-0011-2101 1267088 010542502575006111191207172111192112670889910-0011-2101 1267064 010542502575006111191207172111192112670649910-0011-2101 1267024 010542502575006111191205172111182112670249910-0011-2101 1267021 010542502575006111191205172111182112670219910-0011-2101 1267026 010542502575006111191205172111182112670269910-0011-2101 1267014 010542502575006111191205172111182112670149910-0011-2101 1267019 010542502575006111191205172111182112670199910-0011-2101 1267036 010542502575006111191205172111182112670369910-0011-2101 1267017 010542502575006111191205172111182112670179910-0011-2101 1267006 010542502575006111191205172111182112670069910-0011-2101 1267010 010542502575006111191205172111182112670109910-0011-2101 1267016 010542502575006111191205172111182112670169910-0011-2101 1267011 010542502575006111191205172111182112670119910-0011-2101 1267007 010542502575006111191205172111182112670079910-0011-2101 1267015 010542502575006111191205172111182112670159910-0011-2101 1267013 010542502575006111191205172111182112670139910-0011-2101 1267009 010542502575006111191205172111182112670099910-0011-2101 1267129 010542502575006111200106172111192112671299910-0011-2101 1267012 010542502575006111200106172111182112670129910-0011-2101 1267128 010542502575006111200106172111192112671289910-0011-2101 1267023 010542502575006111200108172111182112670239910-0011-2101 1267022 010542502575006111200108172111182112670229910-0011-2101 1267181 010542502575006111200108172111192112671819910-0011-2101 1267018 010542502575006111200225172111182112670189910-0011-2101 1267114 010542502575006111200527172111192112671149910-0011-2101 1267110 010542502575006111200527172111192112671109910-0011-2101 1267073 010542502575006111200527172111192112670739910-0011-2101 1267077 010542502575006111200527172111192112670779910-0011-2101 1267112 010542502575006111200527172111192112671129910-0011-2101 1267109 010542502575006111200527172111192112671099910-0011-2101 1267074 010542502575006111200527172111192112670749910-0011-2101 1267078 010542502575006111200527172111192112670789910-0011-2101 1267111 010542502575006111200527172111192112671119910-0011-2101 1267081 010542502575006111200527172111192112670819910-0011-2101 1267113 010542502575006111200527172111192112671139910-0011-2101 1267079 010542502575006111200527172111192112670799910-0011-2101 1267076 010542502575006111200527172111192112670769910-0011-2101 1267075 010542502575006111200527172111192112670759910-0011-2101 1267168 010542502575006111200715172205162112671689910-0011-2101 1267162 010542502575006111200715172205162112671629910-0011-2101 1267145 010542502575006111200722172205162112671459910-0011-2101 
Recalling Firm/
Manufacturer		 LivaNova USA Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Njemile Crawley
281-228-7200
Manufacturer Reason
for Recall		 Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
FDA Determined
Cause 2		 Process control
Action On 09/28/2020, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customers via certified 1st class return receipt informing them of an incompatibility warning message will appear with the use of the VNS Therapy Programmers with software version 11.0.4 upon interrogation of certain generators (specifically serial numbers e 1,000,000). This software incompatibility issue is due to the use of a now discontinued 7-digit serial number, thereby resulting in an error in the serial number and causing a communication disruption. For certain generators (SN e 1,000,000) using software version 11.0.4, a warning message will appear. Communication, programming, and diagnostic testing with this subset of affected Model devices will not be possible with software version 11.0.4. This software incompatibility issue does not affect the functionality of the generator itself. The device itself performs as intended when communication, programming and diagnostic testing is done with a compatible software version. Customers are instructed: For patients implanted with a device containing a 7-digit serial number (SN e 1,000,000): 1. Ensure patient has a Therapy Programmer with a software version that is compatible with affected Model 106 devices (SN e 1,000,000) in accordance with the Physicians Manual (including Model 250 version 11.0.3/11.0.5, all current software versions of Model 3000). 2. If you only have a Programmer with software version 11.0.4, contact the Recalling Firm's sales representative or Customer Quality to receive a Programmer that is compatible for all of your patients devices. Note: To check the software version of the Programmer, do the following: 1. Power on the Programmer 2. Review the software version provided on the Main Menu In addition, customer are asked to: 1. Ensure that the customer notification is communicated to all personnel with their organization who needs to be aware of this issue. 2. Fill out and Customer
Quantity in Commerce 134 generators
Distribution U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru
Total Product Life Cycle TPLC Device Report
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.
PMA Database PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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