FDA recall Z-2239-2023

Argon Medical Devices, Inc · Class II · device

Product

Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

Reason for recall

There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status
Ongoing
Initiation date
2023-06-08
Report date
2023-08-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2023