Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver
FDA device recall Z-2239-2023 · posted 2023-07-27 · Open, Classified
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DTK
- Quantity affected
- 3.0
- Distribution
- US Nationwide distribution in the state of TX.
- Date initiated
- 2023-06-08
- Date posted
- 2023-07-27
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTION ELITE VENA CAVA FILTER SYSTEM (K133243) | Rex Medical, L.P. | 2013-12-17 |