Home / Recalls / Advanced Neuromodulation Systems Inc. / Z-0894-2013

Z-0894-2013 Class II Terminated

Recalled by Advanced Neuromodulation Systems Inc. — Plano, TX

Recall Details

Product Type
Devices
Report Date
March 6, 2013
Initiation Date
March 28, 2012
Termination Date
August 15, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
388 units

Product Description

Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

Reason for Recall

Unintended Fluid ingress into the device header has been shown.

Distribution Pattern

Worldwide Distribution - 53 consignees out of the US.

Code Information

Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.

Other recalls by Advanced Neuromodulation Systems Inc.

  • Z-0025-2013 Class II — The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, mu (September 4, 2012)
  • Z-1983-2012 Class II — Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated (December 19, 2011)
  • Z-2281-2012 Class II — The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, recharg (December 19, 2011)
  • Z-2280-2012 Class II — Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connec (December 19, 2011)