Diving certificate:

• Inari Medical called back a device to remove blood clots and blockages from large blood vessels outside the heart, the Food and Drug Administration said Friday.
• The company has updated the labeling of ClotTriever XL catheters, which remain on the market, in response to an issue linked to reports of four injuries and six deaths. Some doctors have experienced problems “when the device becomes entrapped or blocks pulmonary arteries,” the FDA said.
• Inari informed customers about the label changes in July. The company does not expect the measure to have an impact on revenue, said Inari CEO Drew Hykes said during a conference call on second-quarter results in July.

Diving insight:

The events that led to the recall occurred in patients who had catheters inserted through the vein above the collarbone or who had certain types of blood 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 vascular damage and death, the FDA said. categorized the recall as Class I, strictest classification.

Inari’s identification of patient characteristics associated with the side effects led to an update to the product labeling. The company warns against pulling the catheter through certain veins and urges doctors to slowly withdraw 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, tightly adherent or calcified material.”

Speaking to investors in July, Hykes said the labeling change “provides additional procedural and technical guidance … (and) there is no device defect or malfunction.” The device is designed to treat complex deep vein thrombosis, which affects about 15% of patients, the CEO said.

“This is a disease that is associated with quite severe consequences when treated conservatively,” Hykes said. “The change (instructions for use) that we have discussed relates to a very small subset of these patients. It is a particular combination of factors, including the specific type of clot, the specific location and some technical aspects.”

Inari received 510(k) clearance for ClotTriever XL in April 2023.