FDA designates recall of catheter for large blood vessel clot removal as class I
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Key takeaways:
- The FDA designated Inari Medical’s recall of its catheter for clot removal in large blood vessels as class I.
- The recall is due to risk for device entrapment and pulmonary emboli when used in certain situations.
Inari Medical has issued a recall and update to the instructions for use of its 30 mm thrombectomy catheter due to risk for injury and death from device entrapment and pulmonary emboli.
The FDA has identified the recall of the device (ClotTriever XL) as class I, the most serious type, as use of the device may cause injury or death. The FDA noted in an alert that this recall involves an updated instructions for use and not a product removal.
Labeling changes include updates to the device warnings, prior to use, procedure and contraindications sections, according to the FDA alert.
The FDA issued a recommendation to users of these devices that they consider them contraindicated for the removal of fibrous, firmly adherent or calcified material, and that use of an embolic protection device has not been proven effective in venous vasculature.
The company stated that it will revise all catheter training content based on the updated instructions, according to the alert.
The device may become entrapped or block lung arteries when used in patients with the following situations:
- when venous access via the jugular vein is used;
- the attempted removal of a fibrous, organized or adherent thrombus;
- the attempted removal of clots formed by tumor thrombus; and
- the attempted removal of a large-volume thrombus with an inability to remove it in pieces.
Affected catheters include all devices and lot numbers with labeled dates prior to Aug. 1, 2024.
There have been four reported injuries and six deaths related to this issue, according to the FDA alert.
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