FDA Classifies Recall Of Inari Medical's Large Vessel Clot Removal Catheter Device As Most Serious

On Friday, the FDA classified a recall of Inari Medical Inc’s NARI ClotTriever catheter as “most serious.”

The ClotTriever XL Catheter is used to remove 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 updated the use instructions for the ClotTriever XL catheter after discovering serious adverse events caused by the device becoming entrapped or blocking 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 use of the affected product may cause serious adverse health consequences, including device entrapment, vessel damage, and/or blockage of lung arteries (pulmonary emboli), and death.

There have been four reported injuries. There have been six reports of death.

This recall involves updating instructions for using the ClotTriever XL, 30mm device and does not involve removing them from where they are used or sold.

The affected products include all devices and lot numbers with labeled dates before August 1.

Price Action: NARI stock is down 0.62% at $43.07 at the last check on Monday.

Read Next:

• Dexcom’s Stelo Device Brings Affordable Continuous Glucose Monitoring To Type 2 Diabetes Patients.

Don’t miss the opportunity to dominate in a volatile market at the Benzinga SmallCAP Conference on Oct. 9-10 at the Chicago Marriott Downtown Magnificent Mile. Get exclusive access to CEO presentations, 1:1 meetings with investors, and valuable insights from top financial experts. Whether you’re a trader, entrepreneur, or investor, this event offers unparalleled opportunities to grow your portfolio and network with industry leaders. Secure your spot and get your tickets today!