FDA Device recall Z-1983-2012
Eon Mini Neurostimulation (IPG) System (Model 3788)
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Eon Mini Neurostimulation (IPG) System (Model 3788) by Advanced Neuromodulation Systems, citing 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 subseque….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1983-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-12-19 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Neuromodulation Systems |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Model Number 3788. All lots manufactured prior to September 20, 2010. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1983-2012%22
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