FDA Recall
Terminated
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Recall: Z-2385-2021
·
Initiated July 21, 2021
Recall
- Recall Number
- Z-2385-2021
- Event Number
- 88388
- Firm
- Cardiovascular Systems Inc
- FEI Number
- 3004742232
- Product Code
- MCW
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 21, 2021
- Terminated
- March 18, 2026
- Address
- 1225 Old Highway 8 NW, Saint Paul, MN, 55112-6416
Description
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Reason
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.
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.
Distribution
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Quantity
8 units