Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 19, 2018
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 orbi
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardiovascular Systems Inc recalled CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-1001… - a moderate-severity action.
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-1001… was recalled by Cardiovascular Systems Inc in September 19, 2018. Reason: The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.. Check the official notice for the remedy. Verify recall #Z-3021-2018 with the FDA Devices before acting.
The recall
Cardiovascular Systems Inc issued this moderate-severity FDA Devices recall-The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment..
- Moderate
- severity level
- 18 units
- affected scope
- Class II
- classification
- September 19, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3021-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3021-2018) was formally reported on September 19, 2018, with the manufacturer initiating the action on April 13, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardiovascular Systems Inc is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 18.
The documented reason for this recall is: The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3021-2018 |
| Date reported | September 19, 2018 |
| Date initiated | April 13, 2018 |
| Recalling firm | Cardiovascular Systems Inc |
| Firm location | Saint Paul, MN |
| Affected scope | 18 |
| Distribution | US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3021-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardiovascular Systems Inc. Units affected: 18.
Why was this product recalled? ▼
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2018. Severity: Moderate. Recall number: Z-3021-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3021-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 19, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.