Aesculap proSA Adjustment Disc Size Large — Class II medical device recall Z-0989-2014
Terminated recall by Aesculap, Inc., reported 2014-02-26, distributed in AZ, DE, FL, KS, MA, MD, MI, MN…. The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
| Recall number | Z-0989-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2013-12-23 |
| Classified | 2014-02-19 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-10-01 |
| Distributed | AZ, DE, FL, KS, MA, MD, MI, MN, WI |
| Countries outside the US | AU, DE, GB, JP, NO |
| Quantity | 79 |
| Reason classes | specification failure |
| Lot numbers | 4505238953, 4505268906, 4505336973, 4505408485 |
Product
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Reason for recall
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
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-0989-2014. 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.