Advanced Neuromodulation Systems Inc.: Medical Device Recall in 2013 - (Recall #: Z-0894-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 28, 2012

Date Posted: March 6, 2013

Recall Number: Z-0894-2013

Event ID: 61554

Reason for Recall:

Unintended Fluid ingress into the device header has been shown.

Status: Terminated

Product Quantity: 388 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - 53 consignees out of the US.

Voluntary or Mandated:

Voluntary: Firm initiated