Recall Z-3021-2018— Cardiovascular Systems Inc

Class II FDA medical device recall by Cardiovascular Systems Inc, initiated 2018-04-13, terminated 2019-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

Cardiovascular Systems Inc

Classification

Class II

Status

Terminated

Initiated

2018-04-13

Terminated

2019-11-04

Firm location

Saint Paul, MN, United States

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