FDA recall record · openFDA

Inari Medical - Oak Canyon

2 FDA recalls on record (2024–2025) — 2 device. 2 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the co 1

Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1 1

Recalls

ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb Class I 2024-07-19 Artix MT Thrombectomy Device, REF: 32-102 Class II 2025-04-08

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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