Inari Medical is recalling 2,488 units of the ClotTriever XL Catheter (30 mm) to provide updated instructions for use following reports of serious adverse events. The recall was initiated because the device could become entrapped or cause severe complications if used on certain types of firmly attached or calcified material, or if the catheter is pulled through specific access sites like the internal jugular vein. These conditions can lead to life-threatening issues including pulmonary embolism or the need for emergency abdominal surgery.
The catheter may become stuck or overloaded when encountering hardened, calcified, or tumor-based blockages, potentially causing the device to fail or become trapped in the patient's vein. Improper removal techniques, such as pulling the catheter through the neck's internal jugular vein or moving it toward the heart, can lead to device entrapment, blood clots traveling to the lungs, or the need for invasive surgical intervention to remove the device.
Updated Instructions for Use
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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