Recall Z-2239-2023— Argon Medical Devices, Inc

Name: FDA recall Z-2239-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-08

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2023-06-08. It names one FDA 510(k) clearance: K133243. Product: Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797. Reason: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-06-08
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K133243 — OPTION ELITE VENA CAVA FILTER SYSTEMRex Medical, L.P.·cleared 2013-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.