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
This recall has been terminated (originally issued April 13, 2018).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- April 13, 2018
- Terminated
- November 4, 2019
- Recall Number
- Z-3021-2018
- Quantity
- 18
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Distribution
US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX
Lot / Code Info
Lot 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, 145946, and 127026
Root Cause
Device Design
Action Taken
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.