Device product
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Z-0809-2018
Product summary
- Event
- Event 79093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0809-2018
Official wording
Reason: A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Code information: Batch #20034364 and #20034751
Distribution pattern: US Distribution to PA.
Derived failure modes
-
Unknown
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.