Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2 Recalled by LivaNova USA Inc Due to This recall is being initiated due to reports...
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 Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Quantity: 643 units
Why Was This Recalled?
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
Where Was This Sold?
This product was distributed to 47 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, 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