Reported Oct 26, 2022 · Ongoing
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Balt USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BALT USA, LLC · 29 Parker Ste 100 · Irvine, CA · 92618-1667
Is this the product you have?
- Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
- Lot codes and dates
- Model NumberOPTI0208CSS10
- UDI-DI Code00818053025815
- Lot NumberF220601068
- Model NumberOPTI0308CSS10
- UDI-DI Code00818053025891
- Lot NumberF220601089
- Amount recalled
- 41 impacted devices
Where it was sold
Why it was recalled
Product pouch label does not match up with carton label
This product could cause temporary or reversible health problems — stop using it.
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