CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report
Artix MT Thrombectomy Device recalled by Inari Medical - Oak Canyon
Inari Medical - Oak Canyon is recalling Artix MT Thrombectomy Device, distributed nationwide in the US. The recall was initiated on 8 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1728-2025
- FDA event ID
- 96682
- Recalling firm
- Inari Medical - Oak Canyon, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2025
- FDA classified
- 6 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2025 | Recall initiated by company | |
| 6 May 2025 | Classified by FDA | +28 days |
| 14 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Artix MT Thrombectomy Device, REF: 32-102
Where it was distributed
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Nationwide AlaskaCaliforniaColoradoFloridaGeorgiaIllinoisKentuckyMichiganOhioPennsylvaniaTexasWashingtonWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Where was it sold?
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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