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BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Recalled September 14, 2022 · FDA recall Z-1680-2022 · BALT USA
Hazard
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. · FDA Class II
Units
4 devices
Sold at
U.S.: AZ and FL O.U.S.: None
Description
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Product
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Manufacturer(s)
BALT USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →