Every recall we track for BALT USA, LLC — 8 in all — plus the complaints and injury reports the public filed about them.
U.S. recall of Mega Ballast catheters (models MEGABT09180-091110) due to coating lifting in distal lumen. Stop using if you own these models.
BALT USA recalls Optima Coil System models with specific REFs/UDI-DI codes due to radiopaque marker not being visible during angiography, which may not meet manufacturing specifications.
BALT USA recalls Prestige Coil System models with specific REFs/UDI-DI codes due to radiopaque marker not being visible during angiography, potentially affecting medical procedures.
BALT USA recalls Prestige Coil System models due to corrosion of delivery pusher from solder flux residue, which may cause microcatheter blockage and foreign emboli. Affected models include 81 Prestige coil variants with specific model numbers and lot numbers.
BALT USA recalls Optima Coil System devices due to discoloration from corrosion on delivery pusher components, which could break off and cause foreign emboli in patient vasculature. Affected models include Optima Coils 1mm x 1cm, 1mm x 2cm, and others with specific model numbers and lot numbers listed in the recall.
BALT USA recalls Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to pouch label not matching carton labels. This mismatch may cause confusion during medical procedures.
BALT USA recalls Optima Coil System Model OPTI0520CSF10 for endovascular embolization due to release before test report approval from alternate supplier.
BALT USA recalls Optima Coil System due to incorrect labeling potentially causing wrong coil size selection during procedures, risking vessel damage or aneurysm rupture. Affected units have specific model and lot numbers.
