Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel Recalled by Advanced Neuromodulation Systems Inc. Due to As of 11/30/2011, St. Jude Medical has received...
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
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are 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: 30,560 units
Why Was This Recalled?
As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
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