Recalls / —
—#201781
Product
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
- FDA product code
- DTK — Filter, Intravascular, Cardiovascular
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K133243
- Affected lot / code info
- Lot: 11481383, UDI: (00)886333217151
Why it was recalled
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
Root cause (FDA determination)
Under Investigation by firm
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751-5002
Distribution
- Distribution pattern
- US Nationwide distribution in the state of TX.
Timeline
- Recall initiated
- 2023-06-08
- Posted by FDA
- 2023-07-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #201781. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.