Inari Medical has updated its instructions for using some ClotTriever XL catheters in a Class I recall due to injury and death reports.

The company recalled and updated use instructions after discovering serious adverse events caused by the device entering or blocking the lung arteries. The use of affected products could continue to cause serious adverse health consequences, including device entrapment, vessel damage and/or blockage of lung arteries and death.

The ClotTriever XL Catheter is used to remove thrombi and emboli from large blood vessels outside the heart, including the second-largest vein in the body, the vena cava.

This recall affects the ClotTriever XL Catheter, 30mm, with UDI/Model number 00850291007277/41-102. It affects all devices and all lot numbers with labeled dates before August 1, 2024.

Inari Medical said the catheter’s issues have occurred in patients who had the ClotTriever XL inserted through the vein above the collarbone; a clot that is tough, scarred, thick and dense or attached to the vessel; a clot formed in the blood vessel by tumor cells; or an extremely large clot that can’t be removed in pieces.

So far, there have been four reported injuries and six reports of death.

Updated instructions

The FDA has recommended that healthcare providers consider the device contraindicated for the removal of fibrous, firmly adherent, or calcified material. The agency also warned that a clot capture device has not yet been demonstrated effective in venous vasculature.

Inari Medical added the following warning sections to its instructions for use:

• Avoid pulling the ClotTriever XL Catheter caudal to cranial through upper extremity or jugular vein access.
• To prevent an advancing clot from veins into the heart or pulmonary arteries, ensure that the catheter is slowly retracted distally away from the heart while maintaining sheath positions and visualization under fluoroscopy.
• Physician discretion is advised when operating a thrombectomy catheter, as it may embolize some thrombus and/or thrombotic particulate. The potential for extensive or difficult-to-treat pulmonary thromboembolism should be carefully considered when the ClotTriever XL Catheter is used to engage and remove thrombus from large vessels such as the inferior vena cava.

Inari also added several new use instructions for prior use, procedures and contraindications, which can be found in the FDA warning letter here.