Cordis Recalls Optease Vena Cava Filter Due to Printing Error
Cordis is recalling 29,395 Optease Vena Cava Filters because a printing error on one unit caused it to be implanted upside down, requiring an additional procedure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error that resulted in a procedural complication (requiring an additional procedure) rather than a direct, severe physiological injury or death.
Plain-English summary
Cordis Corporation is recalling 29,395 units of the Optease Vena Cava Filter. The recall was initiated after the company identified a printing error on one specific unit where the orientation arrow for the femoral approach was printed in the incorrect direction.
This labeling error resulted in the filter being implanted upside down in a patient. The incorrect orientation required an additional percutaneous procedure to retrieve the filter. The affected devices were distributed worldwide, including in the United States (nationwide, including Hawaii and Puerto Rico), Canada, and Panama.
Healthcare providers and patients should contact Cordis Corporation for further information regarding the recall and potential retrieval procedures.
The recalled product
- Product
- Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant…
- Manufacturer
- Cordis Corporation
- Affected units
- 29,395
Distribution
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