Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-3021-2018 · Posted None

Recalling FirmCardiovascular Systems Inc
Recall StatusTerminated
Product CodeMCX
Date Initiated2018-04-13
Date Terminated2019-11-04
Product Quantity18

Reason for Recall

The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑