DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM recalled over labeling errors

Recall date

July 21, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-2385-2021

FDA classification

Class II

Brand / firm

Cardiovascular Systems Inc

Sold / distributed

US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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