Reported May 14, 2025 · Ongoing
Artix MT Thrombectomy Device, REF: 32-102
Inari Medical - Oak Canyon
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inari Medical - Oak Canyon · 6001 Oak Cyn · Irvine, CA · 92618-5200
Is this the product you have?
- Artix MT Thrombectomy Device
- REF32-102
- Lot codes and dates
- UDI-DI00810123710584
- Lot24100082
- Expiration14 April 2025
- IFUIU-01087 Rev. B
- Amount recalled
- 45
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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