# FDA recall Z-0589-2026

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2025-09-12.

## Product

Option"ELITE Vena Cava Filter System REF 352506070E  UDI-DI code:  00886333217151    The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:  " Pulmonary thromboembolism when anticoagulants are contraindicated  " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced  " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

## Reason for recall

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

## 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. (international) to countries of: China, Panama and Trinidad and Tobago

## Key facts

- **Recall number:** Z-0589-2026
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-12
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0589-2026

## Citation

> AI Analytics. FDA recall Z-0589-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0589-2026. Source: US FDA. Licensed CC0.

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