Aesculap proSA Tool Set Recall: Incorrect Valve Pressure Adjustment Risk
Aesculap recalls proSA Tool Sets (batch #20034364, #20034751) that may not set correct valve pressure in shunt systems, risking improper treatment.
Recall notice
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Contact the company
What happened, in plain English
Aesculap recalls specific batches of proSA Tool Sets used with shunt systems. These tools might not adjust valve pressure correctly, which could lead to improper treatment of the central nervous system. Read more at govinfonow.com/recall/72967-aesculap-prosa-tool-set-recall-incorrect-valve-pressure-adjustment-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72967-aesculap-prosa-tool-set-recall-incorrect-valve-pressure-adjustment-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0809-2018
Cite this page
“Aesculap proSA Tool Set Recall: Incorrect Valve Pressure Adjustment Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72967-aesculap-prosa-tool-set-recall-incorrect-valve-pressure-adjustment-risk. Based on FDA recall #Z-0809-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0809-2018%22&limit=1).
Why it’s dangerous
The adjusting pin in the tool set may not set the correct valve opening pressure. This could cause improper shunt function, potentially leading to complications in central nervous system treatment.
Who’s affected
Patients using the proSA Adjustable Shunt System with the recalled tool batches are affected. Those with shunt systems for central nervous system conditions are most at risk.
How to tell if you have this one
Check for batch numbers 20034364 or 20034751 on the proSA Tool Set packaging. The tool set is used with the proSA Adjustable Shunt System for central nervous system applications.
- Brand
Aescul: Aesculap Implant Systems LLC- Category
Medical device
What to do — step by step
Check Tool Batch Numbers
Look for batch numbers 20034364 or 20034751 on the proSA Tool Set packaging.
Where it went and when
Where it was distributed
Distributed in Pennsylvania.
FDA distribution: “US Distribution to PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0809-2018 (September 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0809-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.