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.
Other recalls by Cardiovascular Systems
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
FDA Device · Class I · 2021-12-29 · Cardiovascular Systems - DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
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…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems
All Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1290-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.