Cardiovascular Systems Inc: Medical Device Recall in 2021 - (Recall #: Z-2385-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 21, 2021

Date Posted: September 8, 2021

Recall Number: Z-2385-2021

Event ID: 88388

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

Lot 340925

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated