CSI — Class II medical device recall Z-3021-2018
Terminated recall by Cardiovascular Systems Inc, reported 2018-09-19, distributed nationwide. The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
| Recall number | Z-3021-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems Inc, Saint Paul, MN, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2018-09-11 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| Lot numbers | 124927, 126925, 127026, 145946, 146337, 148400, 154011, 168143, 171566, 182537, 54512A, 62814B |
| Model numbers | 7-10014, SIP-3000 |
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 for recall
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3021-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.