Artix MT Thrombectomy Device Labeled With Incorrect Vessel Range
Inari Medical is recalling the Artix MT Thrombectomy Device (45 units) because the label specifies an incorrect vessel diameter range. Using the device outside the correct range could damage blood vessels.
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: This is an FDA Class II recall involving a labeling discrepancy for a high-risk cardiovascular device. No illnesses or injuries have been reported, making the hazard theoretical. However, the risk of vascular injury from device misuse due to incorrect specifications is significant, placing this in the 'High' category for risk-of-harm products without yet-reported injuries.
Plain-English summary
Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102) distributed nationwide across multiple states. The device labels and instructions incorrectly specify a vessel diameter range of 2.5–6 mm instead of the correct range of 3–6 mm.
Using the device in vessels at the smaller end of the specified range could incrementally increase radial force on the artery, potentially causing vascular complications. The labeling discrepancy creates a risk that healthcare providers could select the device for use in smaller vessels than the device is actually designed to handle safely.
The recalled devices were distributed to hospitals and medical facilities nationwide. Inari Medical has classified this as a Class II recall. Users who have these devices should verify the correct vessel range (3–6 mm) in the Instructions for Use document (IU-01087 Rev. B) and contact Inari Medical with questions about affected lot 24100082.
The recalled product
- Product
- Artix MT Thrombectomy Device, REF: 32-102
- Manufacturer
- Inari Medical - Oak Canyon
- Hazard
- labeling-error
- vascular-injury
- incorrect-specification
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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