On Friday, the FDA announced a recall of Inari Medical Inc. (NASDAQ:NARI) ClotTriever catheter as “most serious.”

The ClotTriever XL catheter is used to remove blood clots (thrombi) and blockages (emboli) from large blood vessels (10 to 28 mm) outside the heart, including the second largest vein in the body, the vena cava.

Inari Medical has updated the Instructions for Use for the ClotTriever XL catheter after identifying serious side effects caused by the device becoming trapped or blocking the lung arteries (pulmonary embolisms). These events occurred in patients who:

• The catheter is inserted via the vein above the collarbone (venous access via the jugular vein)

• A clot (thrombus) that is tough, scarred (fibrotic), thick and dense (organized) and/or adherent to the vessel (adherent)

• A clot formed by tumor cells in the blood vessel (tumor thrombus)

• An extremely large clot that cannot be removed in pieces (excessive clot volume with the inability to remove it gradually in pieces).

Use of the affected product may result in serious adverse health consequences, including device entrapment, vascular damage and/or blockage of the pulmonary arteries (pulmonary embolism), and death.

There are four reports of injuries and six deaths.

This recall is an update to the instructions for use for the 30mm ClotTriever XL device. It does not involve a removal of the device from the place of use or sale.

Affected products include all devices and batch numbers with labeling dates before August 1.

Price promotion: NARI shares fell 0.62% to $43.07 at last check on Monday.

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This article, “FDA Classifies Recall of Inari Medical’s Large Vessel Clot Removal Catheter Device as Extremely Severe” originally appeared on Benzinga.com

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