Argon Medical Devices recalls Option ELITE Vena Cava Filter System REF 352506070E with UDI-DI code 00886333217151 due to potential venous intimal injuries from excessive force during procedure. Affected units include specific lot numbers.
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Argon Medical Devices is recalling their Option ELITE Vena Cava Filter System REF 352506070E to prevent possible venous intimal injuries during medical procedures. This recall happens because the filter may cause procedural delays or injury if too much force is applied when advancing the dilator.
The filter can cause increased resistance when the dilator is advanced through the introducer sheath. If excessive force is applied during the procedure, this may lead to venous intimal injuries or procedural delays.
Healthcare professionals using the Option ELITE Vena Cava Filter System for pulmonary embolism treatment are most at risk. Patients receiving this procedure may also be affected if the filter is used incorrectly.
Check for the model number 352506070E and UDI-DI code 00886333217151 on the device. Affected units include lot numbers 11633166, 11633125, 11629543, 11629273, and 11628836.
Identify the model number 352506070E and UDI-DI code 00886333217151 on the filter system.
The recall is due to complaints of increased resistance when advancing the dilator within the introducer sheath, which could result in venous intimal injuries if excessive force is applied during the procedure.
Affected lot numbers are 11633166, 11633125, 11629543, 11629273, and 11628836.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Argon Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-0589-2026 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-0589-2026 from Argon Medical Devices. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
