BALT USA recalls Optima Coil System devices due to discoloration from corrosion on delivery pusher components, which could break off and cause foreign emboli in patient vasculature. Affected models include Optima Coils 1mm x 1cm, 1mm x 2cm, and others with specific model numbers and lot numbers listed in the recall.
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
BALT USA is recalling its Optima Coil System devices because corrosion on the delivery pusher component can cause discoloration that may break off and flow into the patient's blood vessels, potentially causing foreign emboli. This risk exists in specific coil models with certain lot numbers.
Corrosion from solder flux residue on the delivery pusher component causes discoloration that can mechanically break off. If this material breaks off, it may flow through the delivery system into the patient's vasculature, potentially causing foreign emboli.
Medical professionals who use the Optima Coil System for neurovascular embolization procedures are most at risk, particularly those who have the affected models listed in the recall with specific lot numbers.
Check for Optima Coil models with specific lot numbers and model numbers listed in the recall, such as OPTI0101CSS10 (1mm x 1cm Complex-10 SuperSoft) or OPTI0102CSS10 (1mm x 2cm Complex-10 SuperSoft).
Review the product's lot number and model number against the list provided in the recall to determine if it is affected.
If the product is affected, contact BALT USA for further instructions on how to handle the device.
The Optima Coil System is a series of specialized coils used in neurovascular embolization procedures to treat intracranial aneurysms and vascular anomalies by creating blood stasis.
Affected models include specific Optima Coils with model numbers like OPTI0101CSS10 (1mm x 1cm Complex-10 SuperSoft) and OPTI0102CSS10 (1mm x 2cm Complex-10 SuperSoft), along with other models listed in the recall with specific lot numbers.
Check the lot number and model number on your device against the list provided in the recall, which includes specific model numbers and lot numbers for affected products.
We’ve drafted a message you can send BALT USA to request your refund or repair — edit it as you like.
Subject: Recall Z-1041-2024 — BALT USA BALT USA Hello, I own a BALT USA that is covered by recall Z-1041-2024 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.
