Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Eon Mini Neurostimulation (IPG) System (Model 3788) Recalled by Advanced Neuromodulation Systems Inc. Due to The firm has received 112 complaints of the...
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 Advanced Neuromodulation Systems Inc. directly.
Affected Products
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Quantity: 25, 255 devices
Why Was This Recalled?
The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Advanced Neuromodulation Systems Inc.
Advanced Neuromodulation Systems Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report