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.
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
BALT USA is recalling specific models of their Optima Coil System because the radiopaque marker used for imaging during procedures wasn't visible as it should be. This could mean the marker wasn't made correctly, potentially affecting how the coils are positioned during medical procedures.
The radiopaque marker is a feature that helps doctors see the coils during angiography procedures using X-rays. If this marker isn't visible as it should be, it may not be manufactured to the correct specifications, which could affect how the coils are positioned during procedures.
Patients who have received the recalled Optima Coil System models with the listed REFs/UDI-DI codes for angiography procedures. The risk is low as the issue relates to marker visibility during imaging, not immediate safety hazards.
Check for the specific REFs/UDI-DI codes listed in the recall notice, which include model numbers like OPTI0156BLK, OPTI0158BLK, and others with their corresponding UDI-DI codes. These are typically found on the product packaging or documentation.
Review the product packaging or documentation for the REFs/UDI-DI codes listed in the recall notice to determine if your Optima Coil System is affected.
The radiopaque marker is a feature that helps doctors see the coils during angiography procedures using X-rays. If it's not visible as it should be, it may not be manufactured to the correct specifications, which could affect how the coils are positioned during procedures.
If your Optima Coil System does not have the specific REFs/UDI-DI codes listed in the recall, there is no action required.
Check the product packaging or documentation for the REFs/UDI-DI codes listed in the recall notice. The affected models include specific codes like OPTI0156BLK, OPTI0158BLK, and others with their corresponding UDI-DI codes.
We’ve drafted a message you can send BALT USA to request your refund or repair — edit it as you like.
Subject: Recall Z-1988-2025 — BALT USA BALT USA Hello, I own a BALT USA that is covered by recall Z-1988-2025 from BALT USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
