Argon Medical Devices recalled 1,821 Vena Cava Filter Systems on September 12, 2025. Increased resistance when advancing the dilator poses a risk of injury. The recall affects devices distributed nationwide and internationally.
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Argon Medical Devices, Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Option ELITE Vena Cava Filter System, REF 352506070E, UDI-DI code: 00886333217151. This device was distributed nationwide in the U.S. and in countries including China, Panama, and Trinidad and Tobago. The recall involves a total of 1,821 units.
The recall stems from complaints of increased resistance when advancing the dilator within the introducer sheath. This issue may lead to procedural delays or risk of venous intimal injuries if excessive force is applied.
The recall has not reported any specific incidents or injuries to date. However, the potential for injury remains a serious concern due to the nature of the issue.
Healthcare providers and patients should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Argon Medical Devices or your healthcare provider for further guidance.
For more information, contact Argon Medical Devices at their customer service line or visit their website. Details about the recall can also be found at the FDA's recall page.
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