Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code:… — Class II medical device recall Z-0589-2026
Ongoing recall by Argon Medical Devices, Inc, reported 2025-12-03, distributed nationwide. Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue
| Recall number | Z-0589-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-11-24 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, PA, TT |
| UPC / GTIN / UDI-DI | 00886333217151 |
| Lot numbers | 11628836, 11629273, 11629543, 11633125, 11633166 |
| Model numbers | 352506070E |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0589-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.