Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
proSA Tool Set used to adjust and verify the proSA Recalled by Aesculap Implant Systems LLC Due to A proSA adjusting pin used to adjust the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap Implant Systems LLC directly.
Affected Products
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Quantity: 2
Why Was This Recalled?
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Where Was This Sold?
This product was distributed to 1 state: PA
About Aesculap Implant Systems LLC
Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report