FDA Device recall Z-0989-2014
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the la…
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the la… by Aesculap, citing the accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0989-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-23 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | AZ, DE, FL, KS, MA, MD, MI, MN, WI |
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
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Identifiers
| code_info | 4 lots: 4505268906, 4505336973, 4505408485, 4505238953 |
|---|
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-0989-2014%22
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