CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report
Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled
Cardiovascular Systems is recalling Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid, 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
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-2385-2021
- 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
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Where it was distributed
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Nationwide ArkansasFloridaIowaOhioPennsylvaniaSouth CarolinaWashingtonWisconsin
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 340925
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
More recalls from Cardiovascular Systems
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Wirion Embolic Protection System, Delivery Catheter recalled | Cardiovascular Systems | Other | 37 states |
| Device | CLASS II | Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled | Cardiovascular Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Peripheral Diamondback 1.25 Solid OAD recalled by Cardiovascular Systems | Cardiovascular Systems | Other | 9 states |
| Device | CLASS II | Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems | Cardiovascular Systems | Other | 9 states |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |