FDAFDA · Food and drugs·Recall number Z-0462-2021
VNS Therapy¿ AspireSR¿ Generator
Published November 25, 2020 · Recall initiated: September 28, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LivaNova USA Inc
- Distributor
- 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
- Lot
- 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 010542502575006111191207172111192112670849910-0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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