Peripheral Diamondback 1 — Class II medical device recall Z-0506-2018
Terminated recall by Cardiovascular Systems Inc, reported 2018-02-14, distributed in FL, IL, MI, MN, MO, NY, SC, TX…. Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for tw
| Recall number | Z-0506-2018 |
|---|---|
| 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 | 2017-09-14 |
| Classified | 2018-02-02 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2019-11-04 |
| Distributed | FL, IL, MI, MN, MO, NY, SC, TX, WI |
| Quantity | 8 |
| Reason classes | labeling |
| Lot numbers | 190217 |
| Model numbers | 7-10011, DBP-150SOLID145 |
Product
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Reason for recall
Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
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-0506-2018. 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.