Food, drugs, devices › Argon Medical Devices, Inc
Device recall: Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver
Argon Medical Devices, Inc (Athens, TX) initiated this device recall on 8 Jun 2023; FDA lists 1 product record under event 92585, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Argon Medical Devices, Inc has 23 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Argon Medical Devices, Inc, Athens, TX.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2239-2023 | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 | 3.0 | Class II | Ongoing | 2 Aug 2023 |
Context
Other enforcement events for Argon Medical Devices, Inc
All 23 events for Argon Medical Devices, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the state of TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.