Argon Medical Devices, REF 352506070E, Option Elite… recallZ-2239-2023 · Argon Medical Devices, Inc · initiated Jun 8, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
FDA root cause category: Under Investigation by firm
Recall details
- Recall number
- Z-2239-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2023
- Posted by the FDA
- Jul 27, 2023
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 3.0
- Product code
- DTK
- FDA submissions
- K133243
- Distribution
- US Nationwide distribution in the state of TX.
Product description
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Code information (models, lots, serial numbers)
Lot: 11481383, UDI: (00)886333217151
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Option Elite Retrievable Vena Cava Filter System 352506070EArgon Medical Devices, Inc. · Filter, Intravascular, Cardiovascular2 recalls3 deaths342 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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