PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 2, 2023 Initiated: June 8, 2023 #Z-2239-2023

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.

Details

Units Affected
3.0
Distribution
US Nationwide distribution in the state of TX.
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797. Recalled by Argon Medical Devices, Inc. Units affected: 3.0.
Why was this product recalled?
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2239-2023.