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Cardiovascular Systems Inc recalls DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Recalled September 8, 2021 · FDA recall Z-2385-2021 · Cardiovascular Systems
Hazard
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 Class II
Units
8 units
Sold at
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Description
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.
Product
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Manufacturer(s)
Cardiovascular Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →