FDA recall Z-2385-2021

Cardiovascular Systems Inc · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-07-21
Report date
2021-09-08
Termination date
2026-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2385-2021