ClotTriever XL Catheter Recall Issued Following Six Patient Deaths

Inari Medical issued an Urgent Medical Device Labeling Correction last month, which the FDA has declared a Class I medical device recall.

Federal safety officials indicate that ClotTriever XL Catheters have been linked to reports of severe and fatal injuries, after the devices became stuck or obstructed arteries in patients’ lungs.

The U.S Food and Drug Administration (FDA) announced a ClotTriever XL Catheter recall on August 23, following multiple reports of “serious adverse events” involving device entrapment and pulmonary embolism.

The problems were first reported by the manufacturer in a device labeling correction issued last month, which the FDA has determined qualifies as a Class I medical device recall, since continued use of the catheters may result in serious injuries or death.

Unlike many FDA recalls, this one does not require medical providers to return the devices or stop using them. Instead, Inari Medical has issued updated instructions for use (IFU) that incorporate additional warnings, which it suggests will avoid the risk of obstructions and pulmonary embolism from the catheters.

The ClotTriever XL Catheter is designed to remove clots (thrombi) and obstructions (emboli) from large blood vessels outside the heart, including the vena cava, the body’s second-largest vein.

Due to problems with the original labeling instructions provided, the catheters have been linked to at least four injuries and six deaths among patients.

On July 19, 2024, Inari Medical issued an Urgent Medical Device Labeling Correction letter, urging medical providers to review and share this letter with relevant personnel and organizations where the ClotTriever XL Catheter may have been transferred, and to promptly complete the Customer Acknowledgement Reply Form. Additionally, all related training content will be updated, and the Inari Medical sales team will reach out to customers to provide the revised training.

The FDA declared the action a medical device recall that affects the ClotTriever XL Catheter, 30mm, with the Unique Device Identifier (UDI) 00850291007277 and model number 41-102. This includes all devices and lot numbers that have labeled dates prior to August 1, 2022.

Inari Medical has updated the use instructions for the ClotTriever XL Catheter to prevent serious adverse events, including device entrapment and pulmonary embolism. The original instructions involved situations where the catheter was inserted through the jugular vein and clots were tough, scarred or excessively large, including those formed by tumor cells.

The new updated instructions call for doctors to avoid pulling the catheter through the upper extremity or jugular vein from caudal to cranial and retract it slowly away from the heart under fluoroscopy. They are also being warned to be cautious of embolization and difficult-to-treat pulmonary thromboembolism, especially in large vessels like the inferior vena cava.

The company recommends doctors should also use a device designed to trap clots to minimize embolization risks, suggesting they remove excessive clot volume in portions instead of all at once. The catheter is not suitable for fibrous, adherent, or calcified material and should not be used for suspected tumor thrombus, the manufacturer and FDA warn.

Customers with questions are urged to contact their local sales representative by calling Inari Customer Care at 877-923-4747, or by sending an email to the Quality department at QA@inarimedical.com.