Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel Recalled by Advanced Neuromodulation Systems Inc. Due to Eon Mini IPGs manufactured in April 2012 could...
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 Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system 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: 56 units
Why Was This Recalled?
Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
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