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U.S. Department of Health and Human Services

Class 2 Device Recall Artix MT Thrombectomy Device

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 Class 2 Device Recall Artix MT Thrombectomy Devicesee related information
Date Initiated by FirmApril 08, 2025
Date PostedMay 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1728-2025
Recall Event ID 96682
510(K)NumberK241894 
Product Classification Peripheral mechanical thrombectomy with aspiration - Product Code QEW
ProductArtix MT Thrombectomy Device, REF: 32-102
Code Information UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Recalling Firm/
Manufacturer		 Inari Medical - Oak Canyon
6001 Oak Cyn
Irvine CA 92618-5200
For Additional Information ContactMazi Kiani
877-923-4747
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 4/8/2025, correction and removal notices were distributed to customers who were asked to do the following: 1) Review notice and the accompanying copy of the device IFU (IU-01087 Rev. C) and disseminate it to any applicable personnel and device users at your facility and network to ensure they are aware of the unused device replacement. 2) Notice should be shared with any organization where affected devices may have been transferred. 3) Complete and return the acknowledgement reply form via email to If you have any questions, please contact your local sales representative, or the firm's Customer Service at 877-923-4747, or Quality department at QA@inarimedical.com.
Quantity in Commerce45
DistributionUS Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QEW
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