BALT USA Recalls
8 recalls on record · March 2, 2022 to November 5, 2025 · Medical Devices
Recalls by year
22
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 5, 2025Medical DevicesFDA
BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09
Hazard: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
June 25, 2025Medical DevicesFDA
BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00
Hazard: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
June 25, 2025Medical DevicesFDA
BALT USA, LLC recalls Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885
Hazard: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
February 14, 2024Medical DevicesFDA
BALT USA, LLC recalls The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices
Hazard: 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.
February 14, 2024Medical DevicesFDA
BALT USA, LLC recalls Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu
Hazard: 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.
October 26, 2022Medical DevicesFDA
BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Hazard: Product pouch label does not match up with carton label
September 14, 2022Medical DevicesFDA
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
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.
March 2, 2022Medical DevicesFDA
BALT USA, LLC recalls The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a
Hazard: Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.