IVC filter recalled due to injury risk
Argon Medical Devices, a Texas-based medtech company focused on interventional devices, has issued a voluntary recall for certain lots of its Option Elite Retrievable Vena Cava Filter. This recall was put in place after the company received reports of “increased resistance” when users advance the dilator within the introducer sheath. If that occurs, Argon Medical Devices warned that it could result in injuries to the patient’s veins if excessive force is used. It may also lead to procedural delays.
According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means using the products could cause “temporary or medically reversible adverse health consequences,” but the risk of a serious adverse events is low.
The Option Elite Retrievable Vena Cava Filter was designed to help protect patients from the risk of recurrent pulmonary embolism (PE). It is implanted into a patient’s inferior vena cava (IVC) and can be retrieved later for short-term protection, or remain in place for long-term protection. According to Argon Medical Devices, this is the only IVC filter approved for popliteal access. Cardiologists may recommend an IVC filter for patients if they present with congestive heart failure, deep vein thrombosis or a high PE risk. The devices are typically implanted by an interventional radiologist or vascular surgeon.
Argon Medical Devices acquired the Option Elite technology from Rex Medical in 2016 as part of a purchase that also included the Cleaner Rotational Thrombectomy System and UltraStream Dialysis Catheter. Prior to that transaction, Argon Medical Devices was already distributing the Option Elite device as part of an exclusive agreement with Rex Medical.
What should customers do?
This Class II recall includes more than 1,800 devices. The FDA alert urges customers to “immediately discontinue” any affected devices and return them to Argon Medical Devices. This information should also be shared with any organizations that may already have the devices on hand. Additional details are available here.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.