Use cautionMedical device recall · FDA · Published April 13, 2018
CSI Orbital Atherectomy Saline Pump Recall: May Switch to Standby Mode
Cardiovascular Systems Inc recalls CSI Orbital Atherectomy Saline Infusion Pump (SIP-3000) due to potential switch to standby mode during use requiring reset. This device is used for atherosclerotic disease treatment in patients with peripheral or coronary artery issues.
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Take action
Contact the company
📍Recalling firmCardiovascular Systems Inc1225 Old Highway 8 NW · Saint Paul, MN 55112-6416
✎ GovInfoNow plain-language explainer
Cardiovascular Systems Inc recalls their Orbital Atherectomy Saline Infusion Pump (SIP-3000) because it may switch to standby mode during use, requiring reset before continuing treatment. This could interrupt critical medical procedures for patients with atherosclerotic disease in arteries. Read more at govinfonow.com/recall/71397-csi-orbital-atherectomy-saline-pump-recall-may-switch-to-standby.
“CSI Orbital Atherectomy Saline Pump Recall: May Switch to Standby Mode.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71397-csi-orbital-atherectomy-saline-pump-recall-may-switch-to-standby. Based on FDA recall #Z-3021-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3021-2018%22&limit=1).
The FDA announced on April 13, 2018, that Cardiovascular Systems Inc is recalling the CSI Orbital Atherectomy System (OAS) Saline Infusion Pump. The pumps may switch to stand-by during use, requiring a reset before continuing treatment.
How to tell if you have it
Brand: Cardiovascular Systems Inc
Product: CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump
According to the FDA, the pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Context
GovInfoNow's records show Cardiovascular Systems Inc has issued three other recalls since September 14, 2017. Other recent recalls of similar products include Medline Neuro Angio Pack Kits (November 26, 2025), Baxter Novum IQ Syringe Pump (August 11, 2026), and Merit Medical Allwell Angioplasty Pack (December 4, 2025).
How to tell if you have this one
Check for model number SIP-3000 and part number 7-10014 on the pump. This device is used for atherosclerotic disease treatment in patients with peripheral or coronary artery issues and is prescription-only.
Brand
Cardiovascular Systems Inc
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Pump Function
Ensure the pump is not switching to standby mode during use by observing for the need to reset it before continuing treatment.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Missouri, Texas.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3021-2018 (April 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3021-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.