ClearanceBrief
Recall Z-2385-2021 ยท MCW Catheter, Peripheral, Atherectomy

Cardiovascular Systems Inc

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

DateJul 21, 2021
StatusTerminated
ReasonThere 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.
Root causeProcess control
ActionThe firm notified its consignees by letter on 07/1/2021. The notice explained the issue and requested the return of the affected products.
Quantity8 units
DistributionUS Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc., Jul 2, 2019