Z-2239-2023Class II

Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or...

Name: Z-2239-2023 Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or...
Creator: Argon Medical Devices, Inc
Published: 2023-06-08
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2023-06-08 / Open, Classified

FDA source

Argon Medical Devices, Inc began a recall of Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 on 2023-06-08. FDA classified it as Class II and gives the reason as "There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2239-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-08
Posted: 2023-07-27
Recalling firm: Argon Medical Devices, Inc
Product: Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Product code: DTK Filter, Intravascular, Cardiovascular
Reason for recall: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
FDA root cause: Under Investigation by firm
Quantity in commerce: 3.0
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: Lot: 11481383, UDI: (00)886333217151

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2239-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2239-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27

Product code DTK

K133243Class IIOption Elite Vena Cava Filter SystemRex Medical, L.P. / cleared 2013-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)