FDA Device recall Z-0589-2026
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of…
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of… by Argon Medical Devices, citing 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 int….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0589-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-12 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
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
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
Identifiers
| code_info | Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.