Recall Z-3021-2018 ยท MCX Catheter, Coronary, Atherectomy
Cardiovascular Systems Inc
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: Peripher
| Date | Apr 13, 2018 |
| Status | Terminated |
| Reason | The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. |
| 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 | 18 |
| Distribution | US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.