Home / Recalls / Argon Medical Devices, Inc / Z-0589-2026

Z-0589-2026 Class II Ongoing

Recalled by Argon Medical Devices, Inc — Athens, TX

FDA device recall Z-0589-2026 was initiated by Argon Medical Devices, Inc on September 12, 2025 and is designated Class II. 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 exc… The recall status is ongoing. Affected quantity: Total devices 1821 (US=1794 and O.U.S.=27) units.

Recall Details

Product Type
Devices
Report Date
December 3, 2025
Initiation Date
September 12, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Total devices 1821 (US=1794 and O.U.S.=27) units

Product Description

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 Pattern

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

Code Information

Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836

Other recalls by Argon Medical Devices, Inc

  • Z-2804-2026 Class II — L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 (June 15, 2026)
  • Z-2803-2026 Class II — L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30c (June 15, 2026)
  • Z-2708-2026 Class I — Arterial Line Kit 20ga x 6, REF: 400115A (June 1, 2026)
  • Z-2706-2026 Class I — General Biospy Tray, REF: GUTS1000 (June 1, 2026)
  • Z-2707-2026 Class I — T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL (June 1, 2026)
  • Z-2704-2026 Class I — Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0 (June 1, 2026)
  • Z-2709-2026 Class I — Bone Marrow Tray, REF: CB0033TL; CB0355TLA (June 1, 2026)
  • Z-2705-2026 Class I — One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular (June 1, 2026)
  • Z-3192-2024 Class II — BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, (July 2, 2024)
  • Z-2638-2024 Class II — L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30c (June 14, 2024)

FDA data resources