FDA Device recall Z-0809-2018
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components by Aesculap Implant Systems, citing A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0809-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-21 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aesculap Implant Systems |
| Distribution | PA |
Product
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Reason
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Identifiers
| code_info | Batch #20034364 and #20034751 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0809-2018%22
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