The US Food and Drug Administration (FDA) has classified the recall of Inari Medical’s ClotTriever XL catheter as the most serious due to reports of patient injury and death.
The ClotTriever XL catheter is designed to remove clots (thrombi) and blockages (emboli) from large blood vessels ranging from 10 to 28mm in diameter, including the vena cava.
As part of the recall, Inari Medical has updated the usage instructions for the ClotTriever XL 30mm device. The recall does not require removing the devices from use or sale.
The affected products encompass all devices and lot numbers with labelled dates before 1 August 2024.
According to the FDA, the use of these devices could potentially lead to serious adverse health effects, such as device entrapment, vessel damage, blockage of lung arteries, or even death.
As of now, the agency has received four reported injuries and six reports of death.
The new warnings emphasise avoiding the insertion of the ClotTriever XL Catheter from caudal to cranial through upper extremity or jugular vein access.
The catheter should be slowly retracted distally away from the heart while maintaining the sheath position and visualisation under fluoroscopy. This approach is recommended in the updated instructions to prevent advancing clots from veins into the heart or pulmonary arteries.
The potential for pulmonary thromboembolism should be carefully considered when using the ClotTriever XL Catheter to remove thrombus from large vessels such as the inferior vena cava (IVC).
In the ‘Before Use’ section, it is now recommended to use a device that entraps clots to lower the risk of embolisation.
In the ‘Procedure’ section, when using the ClotTriever Sheath with the ClotTriever XL Catheter, it is advised to remove portions of the thrombus sequentially if excessive clot volume is present.
The ‘Contraindications’ section has been updated to reflect that the device is currently not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material.
Additionally, reviewing patient history and pre-procedure imaging may help identify patients with these types of lesions. The device is also contraindicated in patients with suspected tumour thrombus.
The FDA advises healthcare providers to consider the device contraindicated for the removal of fibrous, firmly adherent, or calcified material.
On 19 July 2024, Inari Medical issued an ‘Urgent Medical Device Labeling Correction’ letter to all affected customers.
This letter includes updates to the Instructions for Use and recommends that recipients review and distribute the letter and updates to relevant personnel and device users.
