Recall Z-0894-2013— Advanced Neuromodulation Systems Inc.

Name: FDA recall Z-0894-2013
Creator: U.S. Food and Drug Administration
Published: 2012-03-28

Class II · Terminated

Class II FDA medical device recall by Advanced Neuromodulation Systems Inc., initiated 2012-03-28, terminated 2013-08-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.. Reason: Unintended Fluid ingress into the device header has been shown..

Recalling firm: Advanced Neuromodulation Systems Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-03-28
Terminated: 2013-08-15
Firm location: Plano, TX, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.