Inari Medical recalls Artix MT Thrombectomy Device (REF 32-102) due to incorrect vessel size warning on pouch and instructions, which may increase artery injury risk.
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.
Inari Medical is recalling Artix MT Thrombectomy Devices because the product incorrectly lists a vessel size range of 2.5-6 mm instead of the correct 3-6 mm. This could increase the risk of artery damage during use.
The device specifies a vessel range of 2.5-6 mm on its pouch and instructions instead of the correct 3-6 mm. This smaller range could cause the device to apply more force on the artery during procedures, potentially leading to vascular complications.
Healthcare professionals using the Artix MT Thrombectomy Device for clot removal are affected. Those with the device's incorrect vessel size labeling are at risk of potential artery complications.
Check for the Artix MT Thrombectomy Device with REF: 32-102. Look for the UDI-DI: 00810123710584 and Lot: 24100082, which expire April 14, 2025.
Verify the vessel size range on the pouch and instructions for the Artix MT Thrombectomy Device. The correct range is 3-6 mm.
The device incorrectly specifies a vessel size range of 2.5-6 mm instead of the correct 3-6 mm on the pouch and instructions, which could increase artery injury risk.
Check the vessel size range on the device's pouch and instructions. If it shows 2.5-6 mm instead of 3-6 mm, contact Inari Medical for guidance.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Inari Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1728-2025 — Inari Medical Inari Medical Hello, I own a Inari Medical that is covered by recall Z-1728-2025 from Inari Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
