Z-3021-2018Class II

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number...

Name: Z-3021-2018 CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number...
Creator: Cardiovascular Systems Inc
Published: 2018-04-13
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2018-04-13 / Terminated / root cause: design

FDA source

Cardiovascular Systems Inc began a recall of 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... on 2018-04-13. FDA classified it as Class II and gives the reason as "The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3021-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-13
Posted: 2018-09-11
Terminated: 2019-11-04
Recalling firm: Cardiovascular Systems Incorporated
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
Product code: MCX Catheter, Coronary, Atherectomy
Reason for recall: The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent a CSI "Urgent Medical Device Recall" letter dated 13 APRIL 2018. The letter listed the Affected Product, Recall Description, SIP Replacement and Return & contact information. Consignees were notified the pumps will be replaced. Consignees may continue to use their pumps however if a yellow light fault is observed and the troubleshooting per the IFU does not resolve the fault, discontinue use of the pump and notify CSI.
Quantity in commerce: 18
Distribution: US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX
Product codes and lots: Lot 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, 145946, and 127026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3021-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3021-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-11

Product code MCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)