Recall Z-2239-2023 ยท DTK Filter, Intravascular, Cardiovascular
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
| Date | Jul 27, 2023 (initiated Jun 8, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 3.0 |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133243 | OPTION ELITE VENA CAVA FILTER SYSTEM Rex Medical, L.P., Dec 17, 2013 |