| Date Initiated by Firm | July 21, 2021 |
|---|
| Create Date | August 28, 2021 |
|---|
| Recall Status1 |
Terminated 3 on March 18, 2026 |
| 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 |
| FEI Number |
3004742232
|
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. |
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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. |
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| Quantity in Commerce | 8 units |
|---|
| Distribution | US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL |
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| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MCW
|
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