Advanced Neuromodulation Systems recall
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Why was Advanced Neuromodulation Systems recalled?
Unintended Fluid ingress into the device header has been shown.
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 6788. All lots manufactured prior to 03/16/2012 are being recalled.
- Product
- Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
- Recalling firm
- Advanced Neuromodulation Systems Inc.
- Quantity
- 388 units
- Distribution
- Worldwide Distribution - 53 consignees out of the US.
- Recall date
- March 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)