CSI — Class III medical device recall Z-1095-2014
Terminated recall by Cardiovascular Systems, Inc., reported 2014-03-05, distributed nationwide. Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback
| Recall number | Z-1095-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems, Inc., Saint Paul, MN, United States |
| Recall initiated | 2014-01-27 |
| Classified | 2014-02-25 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 318 |
| Lot numbers | 85408, 85412, 85585, 85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949, 87952, 88520, 88524, 88975, 88979, 89498, 89501, 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156 |
| Model numbers | 70058-02, DBEC-125 |
Product
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: 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
Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
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-1095-2014. 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.