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 FDA has identified this recall as the most serious type.
Affected Product
- Product Names: ClotTriever XL Catheter, 30mm
- Unique Device Identifier (UDI)/Model: 00850291007277/41-102
- Lots: All devices and all lot numbers with labeled dates prior to August 1, 2024
What to Do
Follow all updates and additions to the ClotTriever XL Catheter Instructions for Use, which include:
- Warnings section additions
- 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 ClotTrieverXL 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).
- Prior to Use section addition
- To minimize risk of embolization of blood clots, use of a device that entraps clots is recommended.
- Procedure section (ClotTriever Sheath use with ClotTriever XL Catheter) addition
- In the presence of excessive clot volume, it is recommended to sequentially remove portions of thrombus. Avoid removal of the entire clot in one pass.
- Contraindications updates and additions.
- Current: Not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material.
- Additions:
- Review of patient history and pre-procedure imaging may aid in identifying patients with these lesion types.
- Contraindicated in patients with suspected tumor thrombus.
FDA Recommends
Health Care Providers:
- Be aware, based on the FDA’s review of the reported adverse events, the FDA recommends that users consider the device to be contraindicated for the removal of fibrous, firmly adherent, or calcified material.
- Be aware, the use of a clot capture device (e.g. Embolic Protection Device) has not yet been demonstrated to be effective in the venous vasculature.
On July 19, 2024, Inari Medical sent all affected customers an Urgent Medical Device Labeling Correction letter, regarding Instructions for Use updates, recommending the following actions:
- Review the letter and updates, then share it with any relevant personnel and/or device users.
- Share this information with any organization where the ClotTriever XL Catheter may have been transferred.
- Complete the Customer Acknowledgement Reply Form as soon as possible.
The company also noted that all ClotTriever XL Catheter-related training content will be updated to align with these updates. Updated training will be shared to the Inari Medical sales team who will connect with customers to arrange for training.
Reason for Updates to Use Instructions
Inari Medical is updating use instructions for the ClotTriever XL Catheter after discovering serious adverse events caused when the device becomes entrapped or blocks 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 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.
Device Use
The ClotTriever XL Catheter is used for removing 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.
Contact Information
Customers in the U.S. with questions about this recall should contact their local sales representative, Inari Customer Care at 877-923-4747, or the Quality department at QA@inarimedical.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
