Vena cava filters recalled over resistance when advancing the dilator
Argon Medical Devices is recalling 1,821 Option ELITE Vena Cava Filter Systems after complaints of increased resistance when advancing the dilator within the introducer sheath.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states excessive force could cause venous intimal injuries, and no injuries are reported.
Plain-English summary
The Option ELITE Vena Cava Filter System, REF 352506070E, from Argon Medical Devices, is being recalled. The filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the vena cava.
The recall follows complaints of increased resistance when advancing the dilator within the introducer sheath. Argon states this issue could potentially result in procedural delays and/or a risk of venous intimal injuries if excessive force is applied.
The recall covers 1,821 devices, of which the record lists 1,794 in the United States and 27 outside it, carrying UDI-DI 00886333217151, across lots including 11633166, 11633125 and 11629543. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Argon's instructions.
The recalled product
- 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…
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Vascular filter
Distribution
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