# FDA recall Z-3021-2018

> **Cardiovascular Systems Inc** · Class II · device recall initiated 2018-04-13.

## Product

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 angiop

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-3021-2018
- **Recalling firm:** Cardiovascular Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2018-09-19
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3021-2018

## Citation

> AI Analytics. FDA recall Z-3021-2018. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-3021-2018. Source: US FDA. Licensed CC0.

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