Device product
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Z-2239-2023
Product summary
- Event
- Event 92585
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3.0
- Official record key
device-enforcement:Z-2239-2023
Official wording
Reason: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
Code information: Lot: 11481383, UDI: (00)886333217151
Distribution pattern: US Nationwide distribution in the state of TX.
Derived failure modes
-
Unknown
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.