ClotTriever XL Recall 

On August 23, The FDA announced that Inari Medical is recalling their ClotTreiver XL 30 mm device. The purpose of the ClotTriever XL is to treat deep vein thrombosis and help patients with DVT symptoms. 

Deep vein thrombosis (DVT) occurs when blood clots form in the veins. These blood clots are specifically located in deeper veins, like the lower leg, thigh, or pelvis. The ClotTriever XL removes the blood clots from the body by targeting the largest vein in the body.

What is Wrong with the ClotTrieverXL? 

There have been reports of the ClotTriever XL blocking the arteries in the lung and stopping its blood flow, potentially causing pulmonary emboli. Six people have died and four others have been injured by the catheter. 

Recalled Device:

ClotTriever XL Catheter, 30mm

Device Identifier: (UDI) 00850291007277 

Model number: 41-102. 

Recall affects all devices labeled before August 2022

Which Patients Are Affected by the ClotTrieverXL?

Adverse events occurr in patients who had the catheter inserted through the vein above the collarbone, had tumor thrombus, and larger clots that cannot be moved in sections. Patients with tough, scarred (fibrotic), thick, or vessel-attached (adherent) tissue may also experience complications.

The New Warnings and Additions

This is a Class I medical device recall and users are instructed to stop using the catheter because of its dangers of injury and death. Any patients who think the may be affected should consult with their doctor before taking any action. The FDA has required Inari Medical to update their instructions and warnings as folllows: 

• Doctors should avoid avoid pulling the catheter through the upper extremity or jugular vein from caudal to cranial, 
• Doctors should retract the catheter slowly away from the heart under fluoroscopy, and 
• Doctors should be cautious of embolization and difficult-to-treat pulmonary thromboembolism, especially in large vessels like the inferior vena cava.

The FDA and Imari Medical also advise using a device designed to trap clots to minimize embolization risks. It is important to remove larger clots in smaller portions and not all at once. They also caution that the catheter is not suitable for fibrous, adherent, or calcified material, and that it is dangerous to use the catheter for suspected tumor thrombus.

In July 2024, Inari Medical reached out to their customers of the recalled device. The Urgent Medical Device Labeling Correction letter provided users with updated instructions and warnings for the use of the device. 

They advise sharing the updates with other users of the device and organizations where the device may be used. The letter instructs recipients to complete the Customer Acknowledgement Reply Form.

Inari Medical says they will update their related training content for the device and share it with the sales team to ensure customers receive the proper training moving forward.

How do I report a problem?

Health care professionals and consumers who have used the device and suffered injuries can report them to the FDA Safety Information and Adverse Event Reporting Program. The FDA also provides users with information on how to contact Inari Medical and reporting of injuries. 

How We Can Help?

At KBA, we specialize in personal injury cases and  we provide support for individuals who have suffered from defective heart devices. If the ClotTriever has harmed you or a loved one, Contact us. We can help you navigate the legal process and assess your specific case.