Optima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion
BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a risk-of-harm defect. The source describes a theoretical hazard—corroded material may break off during use and enter the patient's vasculature—without reporting any illnesses or injuries. Per the severity rubric, risk-of-harm products without reported injuries are classified as High.
Plain-English summary
The Optima Coil System is a neurovascular embolization device placed via microcatheter to treat intracranial aneurysms and vascular anomalies.
Solder flux residue has caused corrosion on the hypotube component of the delivery pusher. The corroded material may mechanically break off during use and flow through the microcatheter into the patient's blood vessels, potentially causing foreign emboli.
The recall affects 31,785 coils distributed in the United States and internationally. Refer to the FDA recall notice for affected lot numbers and guidance.
The recalled product
- Product
- Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant com
- Manufacturer
- BALT USA, LLC
- Category
- Medical Device — Neurovascular
- Hazard
- foreign-emboli
- corrosion
- solder-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product model number
Distribution
Distributed in 27 states:
- AZ
- CA
- CO
- FL
- GA
- HI
- IL
- KS
- MA
- ME
- MO
- MS
- NC
- NE
- NH
- NJ
- NY
- OH
- OK
- PA
- SC
- SD
- TN
- TX
- VA
- VT
- WI
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