FDAFDA · Food and drugs·Recall number Z-0894-2013
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Published March 6, 2013 · Recall initiated: March 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Unintended Fluid ingress into the device header has been shown.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Distributor
- Worldwide Distribution - 53 consignees out of the US.
- Lot
- Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.