Option ELITE Vena Cava Filter (Argon Medical) – Dilator Resistance (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therap
Brand
Argon Medical Devices, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836
Argon Medical Devices, Inc is recalling Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE F due to Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural de. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 09/12/2025, the firm sent via certified mail an "Urgent - Product Recall Notice" to customers. On 9/2025 the firm sent a follow-up "URGENT - MEDICAL DEVICE RECALL NOTICE" dated 9/29/2025 informing them that Argon Medical Devices is voluntarily recalling five affected lots of the Option ELITE Vena Cava Filter System products in response to reports of increased resistance when advancing the dilator within the introducer sheath. Customers are instructed to: 1. Immediately discontinue use of the affected devices listed in the Recall Letter. 2. Segregate and quarantine the affected devices. 3. Complete and return the response form included at the end of this notification via regular mail or email by 9/26/2025. 4. Return all affected devices to Argon Medical Devices using the instructions provided below. 5. Share this recall notice with the following parties to ensure consignees receive a copy and respond accordingly: a. Anyone within their organization who may use this device. b. Any organization where the potentially affected products have been transferred or further distributed. c. Anyone who needs to be aware within their organization. The product may be returned at Argon s expense to the address below with the returned goods authorization (RGA# 29074) clearly marked. RGA# 29074 Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 USA For any questions contact/email Clayton.Jones@argonmedical.com, or Scott.Bishop@argonmedical.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026