Argon Medical Devices, Inc. is recalling 1,821 units of the OptionELITE Vena Cava Filter System (Model 352506070E) due to reports of increased resistance when moving the dilator through the introducer sheath. This system is used in medical procedures to prevent blood clots from reaching the lungs. If a medical professional uses too much force to overcome this resistance, it can result in procedural delays or serious internal damage.
The increased resistance can cause the device to get stuck during insertion, potentially causing physical damage to the lining of the vein (venous intimal injury) or requiring additional medical intervention if excessive force is applied.
Quantity: Total devices 1821 (US=1794 and O.U.S.=27) units
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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