Advanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints
Advanced Neuromodulation Systems is recalling Eon IPGs due to reports of warmth or heating at the implant site during charging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of physical symptoms (warmth/heating) at the implant site, which aligns with the rubric criteria for Severe severity involving significant injury reports or Class II classifications with adverse events.
Plain-English summary
Advanced Neuromodulation Systems Inc. is recalling the Eon (Model 3716) Implantable Pulse Generator (IPG). This dual-channel, 8-contact receiver is designed to be connected to electrode leads or a lead extension and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. The recall covers 26,388 units of the Eon IPG (Product Code 65-3716) across all lots.
The recall was initiated following 110 patient complaints of warmth or heating at the implant site during charging for the Eon IPG. Additionally, 116 reports of similar symptoms were received for the Eon Mini IPG. The agency has classified this recall as Class II.
The affected devices were distributed nationwide within the US and internationally to numerous countries, including 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 the United Kingdom. Patients with these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- 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…
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Hazard
- Affected units
- 26,388
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots of the Eon (Product Code 65-3716)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Advanced Neuromodulation Systems Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Advanced Neuromodulation Systems Inc.
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