Reported Sep 19, 2018 · Terminated
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.…
Cardiovascular Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiovascular Systems Inc · 1225 Old Highway 8 NW · Saint Paul, MN · 55112-6416
Is this the product you have?
- CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only
- Part Number7-10014
- Model NumberSIP-3000
- Product UsageUsage: 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 belowPeripheral: 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
- CoronaryThe 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
- Lot codes and dates
Lot 12692516814312702614633717156614840018253715401154512A62814B124927145946and 127026
- Amount recalled
- 18
Where it was sold
Why it was recalled
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
This product could cause temporary or reversible health problems — stop using it.
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