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.
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 labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
BALT USA is recalling its Optima Coil System because of a labeling mix-up that could lead to selecting the wrong coil size during medical procedures. This might cause vessel damage, treatment failure, or aneurysm rupture if the incorrect coil is used.
The labeling mix-up could cause medical staff to select the wrong coil size during aneurysm treatment. This might lead to vessel damage, treatment failure, or aneurysm rupture if the incorrect coil is used.
Medical professionals using the Optima Coil System for aneurysm treatment are most at risk. Patients receiving this procedure may be affected if the incorrect coil size is selected.
Check for model numbers OPTI0204CSF10 or OPTI0407CSF10 with lot numbers F210500134 or F210500135. The product is sold by BALT USA and includes a UDI code starting with 008180530260.
Verify the model number and lot number on the product to confirm if it is affected.
Due to a labeling mix-up that could lead to selecting the wrong coil size during procedures, potentially causing vessel damage or aneurysm rupture.
Check the model and lot numbers to see if it is affected. If it is, contact BALT USA for guidance.
Yes, using the incorrect coil size could cause vessel damage, treatment failure, or aneurysm rupture.
We’ve drafted a message you can send BALT USA to request your refund or repair — edit it as you like.
Subject: Recall Z-0660-2022 — BALT USA BALT USA Hello, I own a BALT USA that is covered by recall Z-0660-2022 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.
