Miethke Shunt System accessories Product Usage: — Class II medical device recall Z-1012-2015
Terminated recall by Aesculap, Inc., reported 2015-02-04, distributed nationwide. Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label
| Recall number | Z-1012-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2014-12-17 |
| Classified | 2015-01-26 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 772 |
| Reason classes | labeling |
Product
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Reason for recall
Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
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-1012-2015. 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.