The FDA recently notified the public of a recall issued by Inari Medical regarding updating instructions for use of its ClotTriever XL Catheter 30mm device after reports of injury and death. The recall does not involve the removal or discontinuation of the product itself, but rather pertains to guidelines regarding use of the product.
The ClotTriever XL Catheter device is used by health care professionals to remove clots from large blood vessels external to the heart. The recall applies to products with the UDI# 00850291007277141-102. All lots with dates issued before August 1, 2024, are included.
Inari Medical initially notified customers of this urgent issue on July 19th and released updated instructions for use of the ClotTriever XL Catheter device. The current FDA announcement summarizes the July recall and explains recent additions and corrections made to the instructions for device use.
The recall happened after Inari Medical received four reports of injury and six reports of death connected to use of the ClotTriever XL Catheter. In these instances, the device became trapped and/or caused blockages within the lung arteries. Further investigation determined that the at least one of the following circumstances applied to patients who experienced adverse outcomes linked to the ClotTriever XL Catheter device: Providers inserted the device through the jugular vein; tumor cells had formed the clot targeted for removal; the clot was extremely thick and dense or was attached to the blood vessel; or the clot was very large and could not be removed incrementally.
The FDA and Inari Medical have now issued specific recommendations to health care providers regarding use of the ClotTriever XL Catheter device. The new guidelines specify that the device should not be used to remove extremely dense, fibrous, or calcified clots and should not be used to remove clots caused by tumors. Inari Medical also updated instructions to warn against insertion of the device into the jugular vein. Furthermore, the company advises health care providers to be aware of the risk of embolization when removing “thrombus and/or thrombus particulate” and to retract the device slowly and away from the heart.
Customers can direct any questions about the recall to Inari Customer Care at 877-923-4747 or by email at QA@inarimedical.com.
If you or a loved one has experienced an adverse health outcome linked to a defective medical device, we would like to review the circumstances of your experience and, if appropriate, help you fight for the compensation you deserve for your pain and suffering. You deserve recourse for the physical, emotional, and financial consequences of your injury. TruLaw will help you hold the negligent parties responsible. Get started today by contacting us or taking our free Instant Case Evaluation ℠.