Artix MT Thrombectomy Device recalled for incorrect vessel range specification
Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) because labeling specifies an incorrect vessel range of 2.5-6 mm instead of 3-6 mm, which could increase radial force on arteries and cause vascular complications.
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: This is an FDA Class II recall involving a high-risk medical device (thrombectomy) where labeling mislabeling could result in vascular injury. The source explicitly states the labeling error "has the potential of vascular complications," and no reported injuries are mentioned in the source text, making this a potential-harm scenario that meets the High threshold.
Plain-English summary
Inari Medical is recalling the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) distributed nationwide. The product labeling on the pouch, carton, and Instructions for Use (IFU: IU-01087 Rev. B) specifies an incorrect vessel range of 2.5-6 mm instead of the correct range of 3-6 mm.
This labeling error could result in use of the device on vessels smaller than intended. The increased radial force on smaller arteries has the potential to cause vascular complications.
The recalled lot (24100082) expires April 14, 2025, and was distributed to healthcare facilities in Florida, Illinois, Wisconsin, Kentucky, Texas, California, Ohio, Georgia, Alaska, Michigan, Pennsylvania, Washington, and Colorado. A total of 45 units were affected.
Customers who have received this product should contact Inari Medical immediately regarding appropriate handling and return of the affected units.
The recalled product
- Product
- Artix MT Thrombectomy Device, REF: 32-102
- Manufacturer
- Inari Medical - Oak Canyon
- Affected units
- 45
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
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