FDA recall record · openFDA

BALT USA, LLC

5 FDA recalls on record (2024–2025) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufa 2

Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material w 2

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter 1

Recalls

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09 Class I 2025-09-25 Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00 Class II 2025-05-08 Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885 Class II 2025-05-08 Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu Class II 2024-01-03 The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices Class II 2024-01-03

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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