The Recall Desk
ModerateFDA (Devices)·Z-0103-2023·Announced 2022-10-26

Optima Coil System Pouch Labels Do Not Match Carton Labels

BALT USA is recalling Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to a labeling discrepancy where pouch labels do not match carton labels. These endovascular devices require verification before use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a labeling discrepancy without documented harm or safety incidents, meeting the criteria for Moderate classification per the rubric.

Plain-English summary

The Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10, manufactured by BALT USA, LLC, are subject to a recall. These devices are used in endovascular procedures. The recall is due to a labeling discrepancy: the product pouch label does not match the carton label.

Forty-one devices with this labeling discrepancy have been identified. The devices were distributed worldwide, including in the United States (Florida, Georgia, North Carolina, and Pennsylvania) and internationally (Dominican Republic, India, and Japan).

Healthcare providers and medical facilities with these devices should verify the labeling information on each unit to identify any discrepancies. If you have received these devices and have questions about the labeling mismatch, contact BALT USA, LLC for further instructions and guidance.

The recalled product

Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Manufacturer
BALT USA, LLC
Category
Medical Device — Endovascular Coils
Hazard
  • label-mismatch

Distribution

Distributed nationwide across the United States.

Related recalls

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