BALT USA, LLC Recalls
5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (5)
- Class I
September 25, 2025
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
- Class II
May 8, 2025
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 008100685
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- Class II
May 8, 2025
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- Class II
January 3, 2024
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral va
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
- Class II
January 3, 2024
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and o
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
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