FDA Device recall Z-2239-2023
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly… by Argon Medical Devices, citing there is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2239-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-08 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
Product
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Reason
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
Identifiers
| code_info | Lot: 11481383, UDI: (00)886333217151 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2023%22
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