Aesculap Miethke Shunt System — Class III medical device recall Z-0814-2015
Terminated recall by Aesculap, Inc., reported 2014-12-24, distributed in OK, WI. Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labe
| Recall number | Z-0814-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2014-11-11 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-06-09 |
| Distributed | OK, WI |
| Quantity | 4 |
| Reason classes | labeling |
| Lot numbers | 4506022655 |
| Model numbers | FV660T |
Product
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Reason for recall
Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
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-0814-2015. 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.