Dive Brief:
- Inari Medical has recalled a device for removing clots and blockages from large blood vessels outside the heart, the Food and Drug Administration said Friday.
- The company updated the labeling of the ClotTriever XL catheters, which are staying on the market, in response to an issue linked to reports of four injuries and six deaths. Some physicians have encountered problems “when the device becomes entrapped or blocks the lung arteries,” the FDA said.
- Inari told customers about the label changes in July. The company does not expect any revenue impact from the action, Inari CEO Drew Hykes said on a second-quarter earnings call in July.
Dive Insight:
The events leading to the recall happened in patients who had catheters inserted through the vein above the collarbone or had certain types of clots. The clots were tough, scarred, thick and dense; attached to the vessel; formed in the blood vessel by tumor cells; or extremely large and impossible to remove in pieces, the FDA said.
Such events can have serious health consequences including vessel damage and death, according to the FDA, which categorized the recall as Class I, its most severe classification.
Inari’s identification of patient characteristics associated with the adverse events informed updates to the product label. The company has warned against pulling the catheter through certain veins and asked physicians to slowly retract the device away from the heart and be aware of the risk of blockages. Inari also said the device should not be used to remove “predominantly fibrous, firmly adherent or calcified material.”
Talking to investors in July, Hykes said the label change “offers additional procedural and technical guidance … [and] there’s no device defect or malfunction.” The device is designed to treat complex deep vein thrombosis, which affects around 15% of patients, the CEO said.
“This … is a disease that’s associated with pretty severe outcomes with conservative management,” Hykes said. “The [instructions for use] change that we have discussed refers to a very small subset of these patients. It’s a particular combination of factors, including specific nature of the clot, specific location and some technical aspects.”
Inari received 510(k) clearance for ClotTriever XL in April 2023.