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U.S. Department of Health and Human Services

Class 2 Device Recall STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

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  Class 2 Device Recall STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM see related information
Date Initiated by Firm July 21, 2021
Create Date August 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-2386-2021
Recall Event ID 88388
510(K)Number K190634  
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
Product STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Code Information Lot 340931
Recalling Firm/
Manufacturer		 Cardiovascular Systems Inc
1225 Old Highway 8 NW
Saint Paul MN 55112-6416
For Additional Information Contact Timothy J. Kappers
651-202-4883
Manufacturer Reason
for Recall		 There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
FDA Determined
Cause 2		 Process control
Action The firm notified its consignees by letter on 07/1/2021. The notice explained the issue and requested the return of the affected products.
Quantity in Commerce 8 units
Distribution US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MCW and Original Applicant = Cardiovascular Systems Inc.
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