Aesculap proSA Tool Set Recalled for Incorrect Valve Pressure Adjustment
Aesculap Implant Systems LLC is recalling proSA Tool Sets because the adjusting pin does not set the correct valve opening pressure for the shunt system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to incorrect shunt pressure, posing a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Aesculap Implant Systems LLC is recalling the proSA Tool Set, which is used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components. The recall is due to a defect where the proSA adjusting pin does not set the correct valve opening pressure.
The recall involves two units of the product, specifically Batch #20034364 and #20034751. These units were distributed in the United States to Pennsylvania. No specific dates or additional distribution details are provided in the source text.
Consumers who possess these specific batches of the proSA Tool Set should stop using the adjusting pin to modify the shunt system. They should contact Aesculap Implant Systems LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch #20034364 and #20034751
Distribution
Distributed in 1 state:
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