Inari Medical has updated use instructions for its ClotTriever XL catheter after four injuries and six deaths were reported in association with the device.
The ClotTriever XL is used for removing clots and blockages from large blood vessels outside the heart. The updated instructions come after reports the device had blocked lung arteries or become entrapped, according to an Aug. 23 news release from the FDA.
The company sent a letter to affected customers July 19, with updated use instructions and guidance that training materials for the device were soon to be updated as well.
The following sections of the device use instructions have been updated or added to: warnings, prior to use, procedure and contraindications.
The updates instruct users to avoid removing an entire clot in one pass. The updates also state the device is "not indicated for the removal of predominantly fibrous, firmly adherent or calcified material" and is "contraindicated in patients with suspected tumor thrombus," according to the release.