Advanced Neuromodulation Systems — Class II medical device recall Z-0894-2013
Terminated recall by Advanced Neuromodulation Systems Inc., reported 2013-03-06. Unintended Fluid ingress into the device header has been shown.
| Recall number | Z-0894-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Neuromodulation Systems Inc., Plano, TX, United States |
| Recall initiated | 2012-03-28 |
| Classified | 2013-02-28 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-08-15 |
| Quantity | 388 units |
| Model numbers | 6788 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0894-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.