FDA Device recall Z-1290-2015
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125
- FDA Device
- Class I
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class I recall of Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125 by Cardiovascular Systems, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1290-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-03-04 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cardiovascular Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | 107046, 106992, 106993, 106990. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1290-2015%22
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