FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
- Recall number
- Z-2239-2023
- Recalling firm
- Argon Medical Devices, Inc
- Product
- Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
- Status
- Open, Classified
- Initiated
- 2023-06-08
- Posted
- 2023-07-27
- Terminated
- not on file
- Reason
- 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
- Action
- not on file
- Quantity
- 3.0
- Distribution
- US Nationwide distribution in the state of TX.
- Lot, serial or model codes
- Lot: 11481383, UDI: (00)886333217151
- 510(k) numbers
- ["K133243"]
- PMA numbers
- not on file
- Product code
- DTK
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28