Inari Updates IFU for ClotTriever XL in FDA Class I Recall

August 26, 2024—The United States FDA announced a Class I recall for Inari Medical's ClotTriever XL, 30mm, due to reports of patient injury and death from device entrapment and pulmonary emboli.

The device remains on the market with updated Instructions for Use (IFU), including changes and additions to the Warnings, Prior to Use, Procedure, and Contraindications sections. The FDA reported that Inari informed affected customers regarding the IFU changes via an Urgent Medical Device Labelling Correction letter on July 19, 2024.

The FDA specified that the adverse events (four patient injuries; six deaths) leading to the recall occurred in patients who had: venous access via the jugular vein; fibrotic, organized, and/or vessel-adherent clot; tumor thrombus; [and/or] excessive clot volume unable to be sequentially removed in pieces.

According to the recall notice, the Warnings section in the ClotTriever XL's updated IFU now specified the following:

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

To minimize risk of blood clot embolization, the Prior to Use section now says that use of a device that entraps clots is recommended. The Procedure section states that in the presence of excessive clot volume, sequential removal of portions of thrombus is recommended, while removal of the entire clot in one pass should be avoided.

The current Contraindications stipulate that the device is not indicated for removal of predominantly fibrous, firmly adherent, or calcified material. Additions include that reviewing patient history and preprocedure imaging may aid in the identification of these lesions. The device is also contraindicated in cases of suspected tumor thrombus.

The FDA notes that United States customers can contact their local sales reps, Inari Customer Care at (877) 923-4747, or the Quality department at QA@inarimedical.com.