🔍 RecallPedia

VNS Therapy¿ AspireSR¿ Generator

Class I - Dangerous
🏥 Medical Devices Recalled: September 28, 2020 LivaNova USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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 010542502575006111191206172111182112670549910-0011-2101 1267029 010542502575006111191206172111182112670299910-0011-2101 1267044 010542502575006111191209172111192112670449910-0011-2101 1267060 010542502575006111191209172111192112670609910-0011-2101 1267056 010542502575006111191209172111192112670569910-0011-2101 1267040 010542502575006111191209172111192112670409910-0011-2101 1267055 010542502575006111191209172111192112670559910-0011-2101 1267045 010542502575006111191209172111192112670459910-0011-2101 1267096 010542502575006111191209172111192112670969910-0011-2101 1267057 010542502575006111191209172111192112670579910-0011-2101 1267189 010542502575006111191210172111192112671899910-0011-2101 1267140 010542502575006111191210172111192112671409910-0011-2101 1267164 010542502575006111191210172111192112671649910-0011-2101 1267139 010542502575006111191210172111192112671399910-0011-2101 1267143 010542502575006111191210172111192112671439910-0011-2101 1267163 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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
LivaNova USA Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

VNS Therapy¿ AspireSR¿ Generator

Product Codes/Lot Numbers:

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 010542502575006111191206172111182112670549910-0011-2101 1267029 010542502575006111191206172111182112670299910-0011-2101 1267044 010542502575006111191209172111192112670449910-0011-2101 1267060 010542502575006111191209172111192112670609910-0011-2101 1267056 010542502575006111191209172111192112670569910-0011-2101 1267040 010542502575006111191209172111192112670409910-0011-2101 1267055 010542502575006111191209172111192112670559910-0011-2101 1267045 010542502575006111191209172111192112670459910-0011-2101 1267096 010542502575006111191209172111192112670969910-0011-2101 1267057 010542502575006111191209172111192112670579910-0011-2101 1267189 010542502575006111191210172111192112671899910-0011-2101 1267140 010542502575006111191210172111192112671409910-0011-2101 1267164 010542502575006111191210172111192112671649910-0011-2101 1267139 010542502575006111191210172111192112671399910-0011-2101 1267143 010542502575006111191210172111192112671439910-0011-2101 1267163 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

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0462-2021

Related Recalls

SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).

LivaNova USA

Class I - Dangerous

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

Dec 12, 2024 Infusion Pumps Nationwide View Details →

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

LivaNova USA

Class I - Dangerous

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

Dec 12, 2024 Infusion Pumps Nationwide View Details →

Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

LivaNova USA

Class I - Dangerous

Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Jan 3, 2025 Implants & Prosthetics Nationwide View Details →