FDA classifies Inari Medical's NARI ClotTriever catheter recall as "most serious" due to adverse events.
FDA classifies Inari Medical's NARI ClotTriever catheter device recall as "most serious" due to reports of serious adverse events, including device entrapment and lung artery blockage. The recall affects all devices with labeled dates before August 1 and involves updating the use instructions, procedures, and contraindications. The FDA has recommended healthcare providers consider the device contraindicated for specific cases and warns that a clot capture device has not yet been demonstrated effective in venous vasculature.
August 26, 2024
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