BALT USA recalls Optima Coil System Model OPTI0520CSF10 for endovascular embolization due to release before test report approval from alternate supplier.
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.
BALT USA is recalling its Optima Coil System Model OPTI0520CSF10 for endovascular embolization. The recall is because these products were released to customers before receiving approval for a test report from an alternate supplier.
The products were released to customers before the test report authorizing the use of an alternate supplier's material was approved. This could mean the material used in the device hasn't been fully tested for safety and effectiveness.
Medical professionals using the Optima Coil System for endovascular procedures are likely affected. Patients undergoing these procedures may be at risk if they have the recalled model.
Check for the model number OPTI0520CSF10 on the device or packaging. The UDI-DI code 00818053026164 and lot number F220600470 are also associated with this recall.
Look for the model number OPTI0520CSF10 on the device or packaging.
The products were released to customers before the test report authorizing the use of an alternate supplier's material was approved.
The recall record does not specify a remedy, so no action is required beyond checking if you have the model number OPTI0520CSF10.
The recall record does not describe a specific hazard mechanism that could cause injury, so the risk level is unknown.
We’ve drafted a message you can send BALT USA to request your refund or repair — edit it as you like.
Subject: Recall Z-1680-2022 — BALT USA BALT USA Hello, I own a BALT USA that is covered by recall Z-1680-2022 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.
