Inari Medical, a healthcare company, has initiated a recall of their ClotTriever XL catheters, a device used for removing clots and obstructions from major blood vessels outside the heart, according to a recent announcement by the Food and Drug Administration (FDA). This action comes after the identification of serious issues linked to the device, which have resulted in four reported injuries and six fatalities.
The ClotTriever XL catheters, despite the recall, will remain available on the market but with updated labeling. These updates were communicated to customers by Inari in July, as informed by CEO Drew Hykes during a second-quarter earnings call. Hykes assured that these changes would not affect the company’s revenue projections.
The recall was prompted by specific incidents where the catheter became stuck or caused blockages in the pulmonary arteries (lung arteries). These incidents typically involved catheters that were inserted through the vein above the collarbone or were used to remove certain types of clots. The clots described were notably tough, scarred, thick, and dense. Some were attached to the vessel walls, formed by tumor cells, or were exceptionally large and could not be fragmented for removal.
Such complications carry serious health risks, including vessel damage and death. Consequently, the FDA has classified this recall as Class I, which is the most severe category used to indicate situations where there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.
Following an analysis of the adverse events, Inari has refined the product’s labeling to better define the patient characteristics and conditions under which the device should be used or avoided. New guidelines caution against using the catheter for removal of predominantly fibrous, firmly adherent, or calcified materials. Further, it instructs medical professionals on the careful handling of the device, emphasizing the need to slowly retract the catheter away from the heart and to be cognizant of the potential for causing blockages.
In his discussion with investors, CEO Drew Hykes emphasized that these label changes serve to provide additional procedural and technical guidance and clarified that the changes do not stem from any inherent defect or malfunction of the device itself. He highlighted that the ClotTriever XL is engineered to manage complex deep vein thrombosis, which affects about 15% of patients. He also noted that the updates pertain only to a small subset of these cases, where specific combinations of clot characteristics, location, and procedural techniques intersect.
Despite the severity of the recall, Hykes reassured stakeholders that the updated instructions for use (IFU) target a very narrow spectrum of scenarios and should not broadly impact the general use or effectiveness of the device in treating severe outcomes associated with conservative management of the condition.
In April 2023, Inari received FDA 510(k) clearance for the ClotTriever XL, indicating the device met the necessary regulatory requirements for safety and effectiveness for its intended use less than a standard premarket approval.
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