Diamondback 360 Coronary Orbital Atherectomy System — Class I medical device recall Z-1290-2015
Terminated recall by Cardiovascular Systems, Inc., reported 2015-04-01, distributed nationwide. The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material l
| Recall number | Z-1290-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems, Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-03-04 |
| Classified | 2015-03-20 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2016-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 30 |
| Model numbers | DBEC-125 |
Product
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Reason for recall
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
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-1290-2015. 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.