Use cautionMedical device recall · FDA · Published September 12, 2025
Argon Medical Devices Option ELITE Vena Cava Filter System Recall: Risk of Venous Injury
Argon Medical Devices recalls Option ELITE Vena Cava Filter System REF 352506070E with UDI-DI code 00886333217151 due to potential venous intimal injuries from excessive force during procedure. Affected units include specific lot numbers.
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
Take action
Contact the company
📍Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002
✎ GovInfoNow plain-language explainer
Argon Medical Devices is recalling their Option ELITE Vena Cava Filter System REF 352506070E to prevent possible venous intimal injuries during medical procedures. This recall happens because the filter may cause procedural delays or injury if too much force is applied when advancing the dilator. Read more at govinfonow.com/recall/51305-argon-medical-devices-option-elite-vena-cava-filter-system-recall.
“Argon Medical Devices Option ELITE Vena Cava Filter System Recall: Risk of Venous Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51305-argon-medical-devices-option-elite-vena-cava-filter-system-recall. Based on FDA recall #Z-0589-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2026%22&limit=1).
The FDA announced on Sept. 12, 2025, that Argon Medical Devices, Inc. is recalling the Option ELITE Vena Cava Filter System due to potential venous intimal injuries. The agency stated the recall is voluntary and initiated by the firm.
How to tell if you have it
Brand: Argon Medical Devices
Product: Option ELITE Vena Cava Filter System
Model Number: 352506070E
UDI-DI code: 00886333217151
Lot Numbers: 11633166, 11633125, 11629543, 11629273, 11628836
The hazard
The FDA said the recall is due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potentially result in procedural delays and/or risk of venous intimal injuries if excessive force is applied.
Context
GovInfoNow's records show Argon Medical Devices, Inc. has 15 other recalls on record since Oct. 16, 2018. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (April 21, 2026), Medtronic DLP Cannula Recall (April 21, 2026), and Medtronic Perfusion Systems EOPA Cannula Recall (June 24, 2026).
How to tell if you have this one
Check for the model number 352506070E and UDI-DI code 00886333217151 on the device. Affected units include lot numbers 11633166, 11633125, 11629543, 11629273, and 11628836.
Brand
Argon Medical Devices
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the model number 352506070E and UDI-DI code 00886333217151 on the filter system.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S.…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0589-2026 (September 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0589-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.