Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk
Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a potential risk of pulmonary embolism, a serious but theoretical hazard. No reported illnesses or injuries, classifying this as a risk-of-harm scenario rather than confirmed harm.
Plain-English summary
Argon Medical Devices, Inc. is recalling 3 units of the Option Elite Retrievable Vena Cava Filter, Model REF 352506070E, Lot 11481383, UDI (00)886333217151. This is a medical device designed to filter blood clots from the vena cava.
The FDA identified a potential defect in which the filter may not perform as intended, creating a risk of pulmonary embolism—a serious condition where blood clots block blood flow to the lungs. No illnesses or injuries have been reported at this time.
The recalled devices were distributed in Texas. Patients with this device should contact their healthcare provider immediately for evaluation and guidance. Healthcare providers should contact Argon Medical Devices, Inc. for instructions on device retrieval or replacement.
The recalled product
- Product
- Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- pulmonary-embolism
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 11481383
- UDI: (00)886333217151
Distribution
Distributed nationwide across the United States.
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