Food, drugs, devices › Cardiovascular Systems Inc

Device recall: DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimall

FDA enforcement event 76352 · Class II · initiated 7 Dec 2016 · status Terminated · terminated 23 Mar 2017

DeviceVoluntary: Firm initiated1 product recordSaint Paul, MN

Cardiovascular Systems Inc (Saint Paul, MN) initiated this device recall on 7 Dec 2016; FDA lists 1 product record under event 76352, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 23 Mar 2017. Initiation: voluntary: firm initiated. Cardiovascular Systems Inc has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Cardiovascular Systems Inc, Saint Paul, MN.

Reason for recall

"CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED."

Distribution

"Nationwide Distribution to LA, MS, SC, TX"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1230-2017	DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or…	8 units	Class II	Terminated	1 Mar 2017

Context

91%of 2016 device events are Class II1,232 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Cardiovascular Systems Inc

Initiated	Product (first record)	Type	Class	Records
22 Nov 2021	WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6	Device	Class I	1
21 Jul 2021	DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145	Device	Class II	2
13 Apr 2018	CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Produ	Device	Class II	1
14 Sep 2017	Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patient	Device	Class II	2
14 Apr 2017	CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.	Device	Class II	1
3 Mar 2017	ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide	Device	Class II	1
9 Feb 2017	ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Pro	Device	Class II	1
13 Jun 2016	ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR	Device	Class II	1
4 Mar 2015	Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent	Device	Class I	1
23 May 2014	CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, P	Device	Class I	1

All 13 events for Cardiovascular Systems Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution to LA, MS, SC, TX"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 23 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.