Argon Medical Devices recalled 1,821 Option Elite Vena Cava Filter System devices sold to U.S. hospitals and international distributors. The recall cites a dilator resistance issue within the introducer sheath that could slow procedures and injure venous tissue. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
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 Option Elite Vena Cava Filter System is used to prevent recurrent pulmonary embolism by placing a filter in the inferior vena cava. It is intended for percutaneous placement and is distributed to U.S. hospitals and international distributors.
A defect causes increased resistance when advancing the dilator inside the introducer sheath. This can delay procedures and risk venous injury if excessive force is applied.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals must stop using the device and coordinate with Argon and clinicians for guidance. The recall affects 1,821 devices and may lead to delays in procedures and potential patient safety concerns if the devices are used.
Device labeling, packaging, and recall communications from Argon Medical Devices or the FDA recall page
Refund or replacement typically takes 4-6 weeks after submission of claim
Keep photos of device labeling, retain all recall notices, document communications with healthcare providers and manufacturers
Model Number: 352506070E UDI-DI: 00886333217151 Lot Numbers: 11633166, 11633125, 11629543, 11629273, 11628836 Total Quantity: 1821 units (US 1794; OUS 27) Sold to: U.S. hospitals nationwide; international distribution to China, Panama and Trinidad and Tobago Recall Date: 2025-09-12 Status: ACTIVE Manufacturer: Argon Medical Devices Category: Health & Personal Care, Medical Devices Price: Unknown
No injuries or incidents have been reported.
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