FDA Device recall Z-1095-2014
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicate…
- FDA Device
- Class III
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class III recall of CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicate… by Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1095-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-01-27 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cardiovascular Systems |
| Distribution | US |
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
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
Identifiers
| code_info | Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975…Lot: 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
FDA Device · Class II · 2018-09-19 · Cardiovascular Systems - Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1095-2014%22
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