CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report

Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled

Cardiovascular Systems is recalling Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro, distributed nationwide in the US. The recall was initiated on 21 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 340931

Quantity recalled8 units

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-2386-2021
FDA event ID: 88388
Recalling firm: Cardiovascular Systems, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 21 Jul 2021
FDA classified: 28 Aug 2021
Reported: 8 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

21 Jul 2021	Recall initiated by company
28 Aug 2021	Classified by FDA	+38 days
8 Sep 2021	Published in enforcement report	+11 days

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

Reason for recall

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.

Product as listed by the FDA

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

Where it was distributed

US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL

Nationwide Arkansas Florida Iowa Ohio Pennsylvania South Carolina Washington Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot 340931

Where was it sold?

US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL

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 88388

This product is part of a recall event; the main page for the event is Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled.

Reported	Class	Recall	Company	Reason	Where
8 Sep 2021	CLASS II	Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled	Cardiovascular Systems	Labeling Errors	Nationwide

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	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 1.25 Solid OAD recalled by Cardiovascular Systems	Cardiovascular Systems	Other	9 states
14 Feb 2018Device	CLASS II	Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems	Cardiovascular Systems	Other	9 states

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