Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS Therapy¿ AspireSR¿ Generator Recalled by LivaNova USA Inc Due to Due to an extra digit being inadvertently added...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA Inc directly.
Affected Products
VNS Therapy¿ AspireSR¿ Generator
Quantity: 134 generators
Why Was This 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.
Where Was This Sold?
This product was distributed to 28 states: AL, AK, AZ, CA, CO, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NE, NV, NC, OK, OR, TX, UT, VA, WA, DC
About LivaNova USA Inc
LivaNova USA Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report