CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled
Cardiovascular Systems is recalling CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, distributed nationwide in the US. The recall was initiated on 13 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3021-2018
- FDA event ID
- 80765
- Recalling firm
- Cardiovascular Systems, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2018
- FDA classified
- 11 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 13 Apr 2018 | Recall initiated by company | |
| 11 Sep 2018 | Classified by FDA | +151 days |
| 19 Sep 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX
Nationwide ArizonaCaliforniaFloridaGeorgiaIllinoisMissouriTexas
Questions about this recall
Why was it recalled?
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Which lots are affected?
Lot 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, 145946, and 127026
Where was it sold?
US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cardiovascular Systems
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Wirion Embolic Protection System, Delivery Catheter recalled | Cardiovascular Systems | Other | 37 states |
| Device | CLASS II | Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Peripheral Diamondback 1.25 Solid OAD recalled by Cardiovascular Systems | Cardiovascular Systems | Other | 9 states |
| Device | CLASS II | Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems | Cardiovascular Systems | Other | 9 states |
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| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
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