Argon IVC Filter Lawsuit | 2026 Latest Updates

The Argon Option ELITE IVC filter faces individual product liability suits, and a 2025 FDA recall covers five lots. Plaintiffs allege the filter broke, tore the vena cava or could not be removed. Argon Medical Devices markets the filter, which Rex Medical designed. A Philadelphia jury returned a verdict against Rex in October 2019. No Argon class action or MDL exists. If you had this filter implanted, keep your medical records and ask your doctor about it. Your hospital can tell you which filter was placed and from which lot, so you can check for a recalled lot.

Latest Argon IVC Filter Lawsuit Updates

November 24, 2025: FDA Posts Class 2 Recall

The FDA posted a Class 2 recall, number Z-0589-2026, for five lots of the Option ELITE Vena Cava Filter System [1]. Argon began the recall in September. The recall status is open. Customers were told to discontinue use of the affected devices and return them to Argon at its expense.

September 12, 2025: Argon Begins Option ELITE Recall

Argon Medical Devices began a voluntary recall of five lots. The recall followed complaints of resistance when advancing the dilator. It covers model 352506070E and 1,821 devices, with 1,794 in the United States and 27 outside it.

September 10, 2024: FDA Clears Option ELITE 510(k)

The FDA issued a “Substantially Equivalent” decision on Argon’s 510(k) K242612 for this filter system [2]. The record shows Argon submitted the filing on September 3, 2024. It lists models 352506070E and 352506100E.

June 8, 2023: Argon Starts Earlier Class 2 Recall

Argon began an earlier Class 2 recall, number Z-2239-2023, of one lot of Option Elite filters, lot 11481383 [3]. The FDA posted it on July 27, 2023. The filters carried reference number 352506070E and were sent to Texas.

October 28, 2019: Philadelphia Jury Awards $33.7 Million

A Philadelphia jury awarded $33.7 million to Tracy Reed-Brown against Rex Medical, in a verdict The Philadelphia Inquirer reported the next day [4]. It was the first trial of a Philadelphia mass tort program that consolidated more than 700 lawsuits over Rex Option filters.

January 16, 2014: Argon Announces Over-the-Wire Clearance

Argon announced FDA clearance for the Option ELITE retrievable IVC filter with a new over-the-wire delivery technique, according to a PR Newswire release [5]. The release says Argon began selling the filter in Europe after CE Mark approval.

What Is the Argon Option ELITE IVC Filter?

According to Argon, the Option ELITE retrievable vena cava filter protects against repeat pulmonary embolism (PE) [6]. It can be retrieved or left in place. That depends on whether the patient needs short-term or long-term PE protection. Argon bought the Option Elite technology from Rex Medical in 2016. Before that, Argon distributed the device under an exclusive agreement with Rex.

Who May Be Affected?

People who had a retrievable Option or Option ELITE vena cava filter placed are the ones these suits and the recall concern. Argon’s labeling lists use when anticoagulants cannot be used or have failed. The 2019 trial involved a filter implanted in 2010. Doctors struggled for about three hours in 2016 to remove it. The 2025 recall covers model 352506070E in lots 11633166, 11633125, 11629543, 11629273 and 11628836. Whether a person qualifies for a claim needs an individual legal review.

Reported Injuries or Damages

These injuries are claims in lawsuits, not findings. At the 2019 trial, the plaintiff’s lawyer argued the filter perforated her inferior vena cava. He said it also punctured her pancreas, aorta and renal vein. Argon’s 2025 recall followed reports of more resistance when advancing the dilator within the introducer sheath of the Option ELITE filter system, according to the FDA. Argon said this could cause delays or injure the vein lining if too much force is used. A recall does not show that a filter caused any person’s injury.

Recall and Regulatory Background

The FDA classified the 2025 action as Class 2. Cardiovascular Business says a Class II recall means use could cause temporary or medically reversible harm, and that the risk of serious events is low [7].

Evidence to Preserve

Records about the filter and your care can matter in an implant case. Keep these items:

• Brand, model and lot or UDI number from your implant card or hospital record
• The operative report and the date of placement
• Notes from any retrieval attempt
• CT scans and X-rays showing the filter’s position or a fracture
• Medical records and bills for related care
• Recall letters or notices you received
• Photographs of any removed device
• Messages with doctors, the hospital or the maker

Filing Deadlines

Filing deadlines are set by state law, and yours can depend on where you live and when the injury, removal attempt or diagnosis happened. Ask a lawyer about your own deadline soon. A missed deadline can end a claim, whatever the strength of the facts.

Frequently Asked Questions

Where Were the Recalled Argon IVC Filters Sent?

The recalled Argon IVC filters were sent nationwide in the United States, including Pennsylvania, Georgia and more than 40 other states and the District of Columbia. Another 27 devices went to China, Panama and Trinidad and Tobago.

Did Argon Get Health Canada Approval for the Filter?

Argon received Health Canada approval for the filter, according to its January 2014 announcement. Argon announced that approval together with its FDA clearance for the over-the-wire delivery technique, which the Latest Updates entry describes.

What Did the Rex Option Filter Verdict Decide?

The Rex Option filter verdict found the device defective. Rex argued the original surgeons implanted it incorrectly and that the plaintiff never received follow-up care.

What Does the Research Say About the Filter Recalls?

The research on the filter recalls shows the earlier lot may not perform as intended, which may result in pulmonary embolism. The FDA record lists the cause as under investigation by the firm.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=216137
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242612
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=201781
4. https://www.inquirer.com/business/rex-medical-ivc-option-vein-filter-jury-award-rosemary-pinto-20191029.html
5. https://prnewswire.com/news-releases/optionelite-retrievable-vena-cava-filter-receives-fda-clearance-for-a-new-over-the-wire-delivery-technique-and-enters-new-markets-worldwide-240464641.html
6. https://www.argonmedical.com/product/option-elite-retrievable-vena-cava-filter/
7. https://cardiovascularbusiness.com/topics/clinical/vascular-endovascular/ivc-filter-recalled-due-injury-risk