proSA Tool Set used to adjust and verify the proSA Adjustable Shunt… — Class II medical device recall Z-0809-2018
Terminated recall by Aesculap Implant Systems LLC, reported 2018-03-07. A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening
| Recall number | Z-0809-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2017-09-21 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-08-08 |
| Quantity | 2 |
| Lot numbers | 20034364, 20034751 |
Product
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Reason for recall
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Machine access
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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.