DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM — Class II medical device recall Z-2385-2021
Terminated recall by Cardiovascular Systems Inc, reported 2021-09-08, distributed nationwide. There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro
| Recall number | Z-2385-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems Inc, Saint Paul, MN, United States |
| Recall initiated | 2021-07-21 |
| Classified | 2021-08-28 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2026-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| Reason classes | labeling |
| Lot numbers | 340925 |
| Model numbers | DBP-150SOLID145 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2385-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.