Inari Catheter Recall: Safety Updates Issued

Inari Medical has announced a recall of its catheter and updated its instructions for use following reports of the device becoming entrapped in patients’ lung arteries. This critical update aims to enhance patient safety and inform physicians about ideal usage conditions, an essential move in the continually evolving medtech landscape.

The recall was prompted by incidents involving patients with catheters inserted through the vein above the collarbone or with specific types of clots, characterized as tough, scarred, or impossibly large to remove in pieces. These adverse events raised significant health concerns, including potential vessel damage and death, according to the FDA.

To mitigate these risks, Inari has outlined patient characteristics linked to these incidents, advising against certain procedures and emphasizing slow retraction of the device away from the heart. Additionally, the device should not be used for removing fibrous, firmly adherent, or calcified clots, aligning with the revised product label.

Inari’s recalibration of its catheter guidelines reflects its commitment to patient safety amidst complex deep vein thrombosis treatment, affecting around 15% of patients. The updated instructions serve as critical procedural tools, ensuring physicians can navigate these risks with enhanced clarity. As CEO Bill Hykes states, addressing a narrow subset of high-risk scenarios is pivotal, underlining the importance of this recall in safeguarding patient outcomes