Balt USA, LLC recalls
6 recalls in our records from 2022 to 2025: 6 FDA medical devices.
Recalls with full detail pages
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Balt USA, LLC medical device recall: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Earlier and other recalls
These link to the official agency notice.
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Balt USA, LLC medical device recall: Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875… Official notice ↗
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
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Balt USA, LLC medical device recall: Neurovascular embolization device. The Optima Coil System is a series… Official notice ↗
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as…
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Balt USA, LLC medical device recall: Optima Coil System Model Number OPTI0208CSS10 Official notice ↗
Product pouch label does not match up with carton label
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Balt USA, LLC medical device recall: Optima Coil System Model OPTI0520CSF10. For endovascular embolization Official notice ↗
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.
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Balt USA, LLC medical device recall: The Optima Coil System consists of an implantable embolization coil… Official notice ↗
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…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.