In August 2024, a Class 1 recall (the most serious recall involving a situation where there is a reasonable chance that a product will cause serious health problems or death) was issued for Inari Medical’s ClotTriever XL Catheter, 30mm. 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.
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.
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.
Inari Medical stated with regard to the recall:
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.
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