Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2012
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Advanced Neuromodulation Systems Inc. recalled Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an ai… - a moderate-severity action.
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an ai… was recalled by Advanced Neuromodulation Systems Inc. in July 18, 2012. Reason: The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge du…. Check the official notice for the remedy. Verify recall #Z-1983-2012 with the FDA Devices before acting.
The recall
Advanced Neuromodulation Systems Inc. issued this moderate-severity FDA Devices recall-The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge du….
- Moderate
- severity level
- Class II
- classification
- July 18, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1983-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1983-2012) was formally reported on July 18, 2012, with the manufacturer initiating the action on December 19, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Advanced Neuromodulation Systems Inc. is listed as the recalling firm, operating out of Plano, TX. Federal records list the affected scope as 25, 255 devices.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israe…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25, 255 devices
Related Recalls
6
3 from same agency
Product description
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 for recall
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1983-2012 |
| Date reported | July 18, 2012 |
| Date initiated | December 19, 2011 |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Firm location | Plano, TX |
| Affected scope | 25, 255 devices |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mex… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1983-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Advanced Neuromodulation Systems Inc.. Units affected: 25, 255 devices.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1983-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1983-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 18, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.