FDA Device recall Z-3021-2018
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
- FDA Device
- Class II
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class II recall of CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000 by Cardiovascular Systems, citing the pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3021-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-13 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardiovascular Systems |
| Distribution | US |
Product
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360¿ and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems 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 systems are percutaneous orbital atherectomy systems indicated as therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. Coronary: The DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system 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 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Identifiers
| code_info | Lot 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, 145946, and 127026 |
|---|
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-3021-2018%22
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