CLASS II Device recall · Reported 25 Nov 2020 · FDA Enforcement Report
VNS Therapy¿ AspireSR¿ Generator recalled by LivaNova USA
LivaNova USA is recalling VNS Therapy¿ AspireSR¿ Generator, distributed in 29 states. The recall was initiated on 28 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0462-2021
- FDA event ID
- 86570
- Recalling firm
- LivaNova USA, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Sep 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +50 days |
| 25 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VNS Therapy¿ AspireSR¿ Generator
Where it was distributed
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
AlaskaAlabamaArizonaCaliforniaColoradoDistrict of ColumbiaFloridaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMaineMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Is VNS Therapy¿ AspireSR¿ Generator recalled?
Yes. LivaNova USA recalled VNS Therapy¿ AspireSR¿ Generator on 28 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0462-2021.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LivaNova USA
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA | LivaNova USA | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled | LivaNova USA | Lead & Heavy Metals | 7 states |
| Device | CLASS II | VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA | LivaNova USA | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |