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Cardiovascular Systems, Inc.

Last updated May 24, 2026

What Cardiovascular Systems, Inc. makes

Cardiovascular Systems, Inc. manufactures mechanical atherectomy catheters designed for peripheral and coronary arteries, including line-powered systems for plaque removal. Their portfolio also includes guidewires for cardiac and peripheral vascular procedures, single-use vascular guide-catheters, and embolic protection filtering guidewires. Additionally, they produce saline/lubricant pumps for atherectomy systems and X-ray film rulers for procedural guidance.

The company’s devices are regulated under FDA pathways, including 510(k) clearances, PMA approvals, and UDI compliance, spanning Class I, Class II, and Class III classifications. Products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: csi360.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 877-274-0360
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 024954518

Catalogue (299)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
Diamondback Peripheral	DBP-EX-HANDLE	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-EX-125SOL145	FDA UDI	Class II	Active
Diamondback Peripheral	DBP–200SOLID145	FDA UDI	Class II	Active
Diamondback	DBP-CART-200MAX145	FDA UDI	Class II	Active
Shepherd	PSP18S-19530	FDA UDI	Class II	Active
Stealth	RAD-SC30-175	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-125SOLID145	FDA UDI	Class II	Active
Zilient	04G-195-018	FDA UDI	Class II	Unknown
Stealth	PRD-MAX-200	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-175SOLID180	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-EX-125SOL200	FDA UDI	Class II	Active
Diamondback Coronary	DBEC-125	FDA UDI	Class III	Active
ViperCross	P1VC-035ANG-135	FDA UDI	Class II	Unknown
Diamondback Peripheral	DBP-125MICRO145	FDA UDI	Class II	Unknown
Diamondback Peripheral	DBP-125SOLID60	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-CART-125MIC145	FDA UDI	Class II	Active
Shepherd	PSP18S-30030	FDA UDI	Class II	Active
Stealth	RAD-SC30-125	FDA UDI	Class II	Active
Zilient	12G-195-014	FDA UDI	Class II	Unknown
ViperCross	P1VC-018STR-065	FDA UDI	Class II	Unknown
Diamondback Peripheral	DBP-125MICRO60	FDA UDI	Class II	Active
Diamondback Peripheral	DBP–200CLASS145	FDA UDI	Class II	Active
Shepherd	PSP18S-30004	FDA UDI	Class II	Active
Diamondback Coronary	DBEC-125	FDA UDI	Class III	Active
Diamondback Coronary	GWC-12325LG-FT	FDA UDI	Class III	Active
ViperCath XC	035-XC-200-1	FDA UDI	Class II	Active
Stealth	DBE-150	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-EX-125SOL75	FDA UDI	Class II	Active
Stealth	PRD-SC30-150	FDA UDI	Class II	Active
Diamondback Coronary	SIP-3000	FDA UDI	Class III	Active
ViperCross	P1VC-035STR-090	FDA UDI	Class II	Unknown
ViperCross	P1VC-035STR-065	FDA UDI	Class II	Unknown
Stealth	PRD-SC30-125S	FDA UDI	Class II	Active
Wirion	WRN-D6	FDA UDI	Class II	Active
Zilient	06G-195-014	FDA UDI	Class II	Unknown
Stealth	PRD-SC30-200	FDA UDI	Class II	Active
Extended Length ViperWire Advance	VPR-GW-ELFLEX14	FDA UDI	Class II	Active
Diamondback Peripheral	DBP-EX-175SOL180	FDA UDI	Class II	Active
ViperTrack	VPR-TRK 20	FDA UDI	Class I	Active
Stealth	PRD-SC30-125	FDA UDI	Class II	Active
ViperWire Advance FlexTip	VPR-GW-FT14	FDA UDI	Class II	Active
ViperCross	P1VC-035STR-150	FDA UDI	Class II	Unknown
Diamondback Peripheral	DBP-CART-200CLA145	FDA UDI	Class II	Active
ViperWire Advance FlexTip	VPR-GW-FLEX14	FDA UDI	Class II	Active
Diamondback Coroanry	DBEC-125	FDA UDI	Class III	Active
ViperCross	P1VC-035ANG-065	FDA UDI	Class II	Unknown
Diamondback Peripheral	DBP-CART-125SOL145	FDA UDI	Class II	Active
Shepherd	PSP14S-19512	FDA UDI	Class II	Active
ViperCross	P1VC-035ANG-150	FDA UDI	Class II	Unknown
Viperslide	VPR-SLD2	FDA UDI	Class III	Active

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Authorised Representatives

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Importers

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Authorities

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FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cardiovascular Systems, Inc. has 17 recall records initiated between March 16, 2009, and November 22, 2021, all of which are marked as terminated. The recalls involve various medical devices, including atherectomy systems, guidewires, saline infusion pumps, and labeling corrections, with reasons ranging from potential structural failures (e.g., detachment risks, sheath cracking) and incorrect component inclusion to mislabeling issues (e.g., swapped lot labels, incorrect gauge specifications, and missing or inaccurate shelf-life dates).

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 22, 2021	Z-0394-2022	—	terminated	Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
Jul 21, 2021	Z-2386-2021	—	terminated	There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Jul 21, 2021	Z-2385-2021	—	terminated	There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Apr 13, 2018	Z-3021-2018	—	terminated	The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Sep 14, 2017	Z-0505-2018	—	terminated	Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
Sep 14, 2017	Z-0506-2018	—	terminated	Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
Apr 14, 2017	Z-2122-2017	—	terminated	Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.
Mar 3, 2017	Z-1771-2017	—	terminated	Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip.
Feb 9, 2017	Z-1877-2017	—	terminated	CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.
Dec 7, 2016	Z-1230-2017	—	terminated	CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Jun 13, 2016	Z-2051-2016	—	terminated	The pouch label was missing the use by date (UBD) of 2018-04.
Mar 4, 2015	Z-1290-2015	—	terminated	The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
May 23, 2014	Z-2155-2014	—	terminated	CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
Jan 27, 2014	Z-1095-2014	—	terminated	Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
Jun 18, 2012	Z-1959-2012	—	terminated	CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Apr 16, 2009	Z-2028-2009	—	terminated	CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s
Mar 16, 2009	Z-1250-2009	—	terminated	CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.