Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- Argon Medical Devices
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Argon Medical Devices
- Product type
- Inferior Vena Cava Filter System
- Model numbers
- 352506070E (UDI-DI 00886333217151) Lot numbers: 11633166, 11633125, 11629543, 11629273, 11628836
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Argon Medical Devices, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Option Elite Vena Cava Filter System is used to prevent recurrent pulmonary embolism by placing a filter in the inferior vena cava. It is intended for percutaneous placement and is distributed to U.S. hospitals and international distributors.
Why This Is Dangerous
A defect causes increased resistance when advancing the dilator inside the introducer sheath. This can delay procedures and risk venous injury if excessive force is applied.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals must stop using the device and coordinate with Argon and clinicians for guidance. The recall affects 1,821 devices and may lead to delays in procedures and potential patient safety concerns if the devices are used.
Practical Guidance
How to identify if yours is affected
- Confirm device is Option Elite Vena Cava Filter System (REF 352506070E)
Where to find product info
Device labeling, packaging, and recall communications from Argon Medical Devices or the FDA recall page
What timeline to expect
Refund or replacement typically takes 4-6 weeks after submission of claim
If the manufacturer is unresponsive
- Escalate to hospital compliance department
- File a complaint with FDA if manufacturer is unresponsive
- Keep documentation of all communications and recalls
How to prevent similar issues
- Check recall notices for all implanted devices
- Use only approved distributors and hospital procurement channels
- Verify model, UDI-DI, and lot numbers before use or implantation
Documentation advice
Keep photos of device labeling, retain all recall notices, document communications with healthcare providers and manufacturers
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Product Details
Model Number: 352506070E UDI-DI: 00886333217151 Lot Numbers: 11633166, 11633125, 11629543, 11629273, 11628836 Total Quantity: 1821 units (US 1794; OUS 27) Sold to: U.S. hospitals nationwide; international distribution to China, Panama and Trinidad and Tobago Recall Date: 2025-09-12 Status: ACTIVE Manufacturer: Argon Medical Devices Category: Health & Personal Care, Medical Devices Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,821 total units recalled (US 1,794; OUS 27)
- Model 352506070E, UDI-DI 00886333217151
- Recall date 2025-09-12; status ACTIVE
- Hazard: increased resistance during dilator advancement within the introducer sheath
- No injuries or incidents reported
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Safety Guide
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