People's Justice

Case guide

IVC filter recalls: check the exact notice

The cited Option ELITE recall concerns five lots and a problem during placement. It does not recall every filter or promise money.

See If You Qualify

Free · No obligation · About 2 minutes

Updated Oct 4, 202610 sources

This may apply to you if

  • These suggestions help you prepare for a claim check. They are not a firm's acceptance rules.
  • For a check, gather the filter brand/model and implant date if known.
  • Describe the harm and later care in your own words.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

United States Food and Drug Administration · Federal medical-device safety agency

Finding: The FDA record posted November 24, 2025 describes five specified Option ELITE lots with delivery-system resistance. Its customer return instructions are not a command to remove every implanted filter.

FDA exact Option ELITE recall record Z-0589-2026 (opens in a new tab) · Nov 24, 2025 · Checked Oct 3, 2026

The evidence and its limits

54 United States study sites; first-author affiliation Indiana University · Journal of Vascular and Interventional Radiology · 2023

PRESERVE: Outcomes at 12 months

Design:
Cohort
Participants:
1429 consenting participants; 1421 received filters.
Finding:
Prespecified safety and effectiveness goals were met, with adverse events also recorded, including a death during attempted retrieval.
Main limitation
Prospective nonrandomized study, varied follow-up and many removed filters; no randomized untreated comparison or lifetime model-specific risk estimate. Original author abstract read; full paper and funding/conflicts not reviewed.

Read the source: PRESERVE: Outcomes at 12 months (opens in a new tab) · Checked Oct 3, 2026

The short answer

Which recall is described here?
The FDA record concerns Argon Option ELITE, reference 352506070E. It lists five affected lots, so the product and lot must be checked. [9]
What problem does that recall report?
A tool can meet resistance inside a tube during placement. If too much force is used, the procedure may be delayed or the vein injured. [9]
Is FDA removal guidance the same as a recall?
No. FDA describes a doctor’s review of clot risk and possible removal. Some filters stay in place for life. [5]
Do court allegations prove a recall for all brands?
No. Bard’s court order describes disputed device claims. A claim in court and a recall of listed lots do not cover the same things. [7]

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

The cited Option ELITE recall concerns five lots and a problem during placement. It does not recall every filter or promise money. It does not tell you to remove your implant.

Which recall is described here?

The FDA record concerns Argon Option ELITE, reference 352506070E. It lists five affected lots, so the product and lot must be checked.

The actual record is Z-0589-2026, initiated September 12, 2025 and posted November 24, 2025. The year in the recall code is not the implant date or a nationwide legal deadline.

What problem does that recall report?

A tool can meet resistance inside a tube during placement. If too much force is used, the procedure may be delayed or the vein injured.

The notice is about a delivery-system problem. Its instructions tell customers to discontinue affected products, quarantine them and arrange return. They do not tell every patient with an implanted filter to have it removed.

Is FDA removal guidance the same as a recall?

No. FDA describes a doctor’s review of clot risk and possible removal. Some filters stay in place for life.

The 2021 authorization of a laser retrieval tool concerns certain embedded devices after earlier methods fail. It is not a finding that all other filters are defective or that retrieval is right for everyone.

Do court allegations prove a recall for all brands?

No. Bard’s court order describes disputed device claims. A claim in court and a recall of listed lots do not cover the same things.

The order also describes cases sent to other courts after shared proceedings. It does not turn the Option ELITE notice into a Bard action. Product names, dates and legal parties should stay separate.

What does the clinical evidence add?

A filter study recorded both benefits and harm. That result is not a recall of all brands. It does not prove that your own device caused harm.

The study placed filters in 1421 consenting participants, with varying follow-up and many removals. It was not a randomized lifetime test. Ask how any finding relates to the actual model in your implant record.

What can I prepare for a notice or claim check?

Keep device details, the notice and care records. Ask your care team about treatment. Ask a lawyer about the filing rule for you.

Request missing covered medical copies through the provider. Mark uncertain lot or date details instead of assuming a match. A recall date does not substitute for an individual legal assessment.

Find out where you stand.

The review is free and private. Asking for it doesn’t commit you to anything.

Register your interest

Sources

  1. ABA Model Rule 1.5: feesABA Model Rule 1.5: fees
  2. Southern District of New York: time limitsSouthern District of New York: time limits · court
  3. 45 CFR 164.524: access to health records45 CFR 164.524: access to health records · regulator
  4. Johnson: PRESERVE12-month outcomes, original author abstractJohnson: PRESERVE12-month outcomes, original author abstract · study
  5. FDA: authorization of laser filter-removal deviceFDA: authorization of laser filter-removal device · regulator
  6. FDA: Option ELITE recallZ-0589-2026FDA: Option ELITE recallZ-0589-2026 · regulator
  7. Campbell: Bard amended final remand/transfer orderDoc22042Campbell: Bard amended final remand/transfer orderDoc22042 · court
  8. JPML: Cook filter transfer orderJPML: Cook filter transfer order · court
  9. FDA exact Option ELITE recall record Z-0589-2026
  10. Johnson et al.: original PRESERVE abstract and metadata

Checked against 10 primary sources by People's Justice editors · Updated

How we make money

People's Justice research team · Updated Oct 4, 2026