[pending] Artix MT Thrombectomy Device, REF: 32-102
Pending LLM rewrite. Source: FDA_DEVICE Z-1728-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
The recalled product
- Product
- Artix MT Thrombectomy Device, REF: 32-102
- Manufacturer
- Inari Medical - Oak Canyon
- Category
- Medical Device — Devices
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 (3)
- UDI-DI: 00810123710584
- Lot: 24100082
- Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Distribution
Distributed nationwide across the United States.
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