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Balt USA, LLC FDA Recalls
8 recalls on file across devices, 1 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09Class ISep 25, 2025Due to an identified manufacturing defect involving coating |
| Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00Class IIMay 8, 2025Due to radiopaque (RO) marker was not visible during angiogr |
| Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885Class IIMay 8, 2025Due to radiopaque (RO) marker was not visible during angiogr |
| Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascuClass IIJan 3, 2024Discoloration was identified along the delivery pusher which |
| The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices Class IIJan 3, 2024Discoloration was identified along the delivery pusher which |
| Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.Class IISep 7, 2022Product pouch label does not match up with carton label |
| Optima Coil System Model OPTI0520CSF10. For endovascular embolization.Class IIJul 26, 2022Products were released to customers prior to the approval an |
| The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to aClass IIJan 4, 2022Due to Label/Pouch mix-up. Pouches incorrectly labeled. Inc |