CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report

Peripheral Diamondback 1.25 Solid OAD recalled by Cardiovascular Systems

Cardiovascular Systems is recalling Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system, distributed in 9 states. The recall was initiated on 14 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 190097 Part #: 7-10012 Model # DBP-125SOLID145

Quantity recalled8

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-0505-2018
FDA event ID: 78897
Recalling firm: Cardiovascular Systems, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2017
FDA classified: 2 Feb 2018
Reported: 14 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Sep 2017	Recall initiated by company
2 Feb 2018	Classified by FDA	+141 days
14 Feb 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

Where it was distributed

FL, IL, MI, MN, MO, NY, SC, TX, and WI

Florida Illinois Michigan Minnesota Missouri New York South Carolina Texas Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145

Where was it sold?

FL, IL, MI, MN, MO, NY, SC, TX, and WI

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.

Other products in this recall event

1 other product · FDA event 78897

This product is part of a recall event; the main page for the event is Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems.

Reported	Class	Recall	Company	Reason	Where
14 Feb 2018	CLASS II	Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems	Cardiovascular Systems	Other	9 states

More recalls from Cardiovascular Systems

All 15

Reported	Class	Recall	Company	Reason	Where
29 Dec 2021Device	CLASS I	Wirion Embolic Protection System, Delivery Catheter recalled	Cardiovascular Systems	Other	37 states
8 Sep 2021Device	CLASS II	Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled	Cardiovascular Systems	Labeling Errors	Nationwide
8 Sep 2021Device	CLASS II	Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled	Cardiovascular Systems	Labeling Errors	Nationwide
19 Sep 2018Device	CLASS II	CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled	Cardiovascular Systems	Device Malfunction	Nationwide
14 Feb 2018Device	CLASS II	Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems	Cardiovascular Systems	Other	9 states

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