FDA Device recall Z-0894-2013
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator by Advanced Neuromodulation Systems, citing unintended Fluid ingress into the device header has been shown.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0894-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-28 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Neuromodulation Systems |
| Distribution | n/a |
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.
Identifiers
| code_info | Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0894-2013%22
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