Six Deaths Connected to Inari ClotTriever XL Recall

Inari Medical, on July 19, sent customers an Urgent Medical Device Labeling Correction Letter regarding updates for its ClotTriever XL catheter instructions for use (IFU) after “discovering serious adverse events caused when the device becomes entrapped or blocks the lung arteries (pulmonary emboli),” according to the recall notice, which has now been identified as Class I by FDA. The recall is considered a correction and does not involve product removal.

The ClotTriever XL catheter is a device used to remove clots and blockages from large blood vessels — measuring between 10 to 28 mm — outside the heart, including the vena cava.

The adverse events that reportedly jumpstarted the recall included patients who had the catheter inserted through the vein above the collarbone; had a clot that was tough, scarred, thick and dense, and attached to the vessel; had a clot formed in the blood vessel by tumor cells; and had an extremely large clot that can’t be removed in pieces.

If the device is used while not following the IFU, it may cause serious health consequences like device entrapment, vessel damage, blockage of lung arteries, and death. There have been four reported injuries, and six reported deaths connected with the issue, according to the recall notice.

Multiple updates and additions have been added to the ClotTriever XL catheter’s IFU, including additions under the warnings section, prior to use section, procedure section, contraindications, as well as other additions.

Warning section:

Prior to use section:

Procedure section:

Contraindications:

Additions:

In tandem with updating the devices IFU, FDA echoed the company’s stance that users should consider the device to be contraindicated for the removal of fibrous, firmly adherent, or calcified material, and to be aware that the use of a clot capture device has not yet been demonstrated to be effective in the venous vasculature.