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Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli

Inari Medical is updating use instructions for the ClotTriever XL Catheter after discovering serious adverse events caused when the device becomes entrapped or blocks the lung arteries (pulmonary emboli). These events occurred in patients who had:

• The catheter inserted through the vein above the collarbone (venous access through the jugular vein)
• A clot (thrombus) that is tough, scarred (fibrotic), thick and dense (organized), and/or attached to the vessel (adherent)
• A clot formed in the blood vessel by tumor cells (tumor thrombus)
• An extremely large clot that can’t be removed in pieces (excessive clot volume with an inability to sequentially remove it in pieces).

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold.

Questions?

Customers in the U.S. with questions about this recall should contact their local sales representative, Inari Customer Care at 877-923-4747, or the Quality department at QA@inarimedical.com.