FDA Device recall Z-1230-2017
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, cathete…
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, cathete… by Cardiovascular Systems, citing CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1230-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-07 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardiovascular Systems |
| Distribution | US |
Product
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Reason
CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Identifiers
| code_info | Lot: 171686, Expiration: 2018-09-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1230-2017%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.