Eon Mini Neurostimulation recall
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk…
Why was Eon Mini Neurostimulation 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number 3788. All lots manufactured prior to September 20, 2010.
- 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…
- Recalling firm
- Advanced Neuromodulation Systems Inc.
- Quantity
- 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, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)