# FDA recall Z-2385-2021

> **Cardiovascular Systems Inc** · Class II · device recall initiated 2021-07-21.

## 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

- **Recall number:** Z-2385-2021
- **Recalling firm:** Cardiovascular Systems Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2385-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2385-2021. Source: US FDA. Licensed CC0.

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