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Stop using now Medical device recall · FDA · Published June 8, 2023

Argon Medical Elite Vena Cava Filter Recall: Pulmonary Embolism Risk

Argon Medical recalls Elite Retrievable Vena Cava Filters due to potential failure causing pulmonary embolism. Affected units have specific model and lot numbers.

🇺🇸 FDA recall #Z-2239-2023Medical deviceArgon Medical ›
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Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002
✎ GovInfoNow plain-language explainer

Argon Medical is recalling Elite Retrievable Vena Cava Filters that may not work properly, risking pulmonary embolism. This is a serious medical device issue requiring immediate attention. Read more at govinfonow.com/recall/57877-argon-medical-elite-vena-cava-filter-recall-pulmonary-embolism-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57877-argon-medical-elite-vena-cava-filter-recall-pulmonary-embolism-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2239-2023

Cite this page

“Argon Medical Elite Vena Cava Filter Recall: Pulmonary Embolism Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57877-argon-medical-elite-vena-cava-filter-recall-pulmonary-embolism-risk. Based on FDA recall #Z-2239-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2023%22&limit=1).

The FDA announced on June 8, 2023, that Argon Medical Devices, Inc. is recalling its Option Elite Retrievable Vena Cava Filter due to potential performance failure leading to pulmonary embolism. The agency issued recall number Z-2239-2023 for the Class II device distributed in Texas.

How to tell if you have it

  • Brand: Argon Medical
  • Product: Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery
  • REF: 352506070E
  • Lot: 11481383
  • UDI: (00)886333217151

The hazard

According to the FDA, the vena Cava Filter may not perform as intended, which may result in pulmonary embolism. The record does not report specific incidents or injuries associated with this recall.

Context

GovInfoNow's records show Argon Medical Devices, Inc. has 15 other recalls on record since October 16, 2018. Other recent recalls of similar products include Medline Oxygen Masks Recall (November 21, 2025), Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026), and Medline ViewFlex Xtra ICE Catheters Recall (December 22, 2025).

How to tell if you have this one

Check for the model number REF 3525060: 352506070E on the device or packaging. Lot number 11481383 and UDI (00)886333217151 are also identifiers.

  • Brand
    Argon Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discontinue use of the Elite Retrievable Vena Cava Filter if it is the recalled model.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Jun 8, 202312. FDA classified it Class II: Jul 27, 202323. Published in FDA’s Enforcement Report: Aug 2, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-2239-2023 (June 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2239-2023 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA