Artix MT Thrombectomy Device — Class II medical device recall Z-1728-2025
Ongoing recall by Inari Medical - Oak Canyon, reported 2025-05-14, distributed nationwide. Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather t
| Recall number | Z-1728-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inari Medical - Oak Canyon, Irvine, CA, United States |
| Recall initiated | 2025-04-08 |
| Classified | 2025-05-06 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 45 |
| UPC / GTIN / UDI-DI | 00810123710584 |
| Lot numbers | 24100082, IU-01087 |
| Model numbers | 32-102 |
| Expiration dates | 2025-04-14 |
Product
Artix MT Thrombectomy Device, REF: 32-102
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1728-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.