Device product
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Z-2385-2021
Product summary
- Event
- Event 88388
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2385-2021
Official wording
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.
Code information: Lot 340925
Distribution pattern: US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Derived failure modes
-
Labeling or packaging
mislabeling