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Open, Classified

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

FDA Recall Z-2239-2023 · Posted 2023-07-27

Recalling FirmArgon Medical Devices, Inc
Recall StatusOpen, Classified
Product CodeDTK
Date Initiated2023-06-08
Product Quantity3.0

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the state of TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K133243OPTION ELITE VENA CAVA FILTER SYSTEMRex Medical, L.P. · 2013-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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