CLASS II Device recall · Reported 5 Sep 2012 · FDA Enforcement Report
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed recalled
Advanced Neuromodulation Systems is recalling Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed, distributed nationwide in the US. The recall was initiated on 19 Dec 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2280-2012
- FDA event ID
- 61171
- Recalling firm
- Advanced Neuromodulation Systems, Plano, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2011
- FDA classified
- 27 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Dec 2011 | Recall initiated by company | |
| 27 Aug 2012 | Classified by FDA | +252 days |
| 5 Sep 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. 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.
Where it was distributed
Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Questions about this recall
Why was it 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.
Which lots are affected?
All lots of the Eon (Product Code 65-3716)
Where was it sold?
Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 61171This product is part of a recall event; the main page for the event is The Eon Mini Neurostimulation (IPG) System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Eon Mini Neurostimulation (IPG) System recalled | Advanced Neuromodulation Systems | Other | Nationwide |
More recalls from Advanced Neuromodulation Systems
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brio DBS System implantable neurostimulator, IPG or R-ipg recalled | Advanced Neuromodulation Systems | Other | TX |
| Device | CLASS II | The Eon Mini Implantable Pulse Generator recalled | Advanced Neuromodulation Systems | Device Malfunction | Nationwide |
| Device | CLASS II | The Eon Mini Neurostimulation (IPG) System recalled | Advanced Neuromodulation Systems | Other | Nationwide |
| Device | CLASS II | Eon Mini Neurostimulation (IPG) System recalled | Advanced Neuromodulation Systems | Device Malfunction | Nationwide |
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