Lower riskMedical device recall · FDA · Published July 21, 2021
DIAMONDBACK 360 GEN2 Orbital Atherectomy System Recall: Mislabeling Risk
Cardiovascular Systems recalls DIAMONDBACK 360 GEN2 peripheral orbital atherectomy systems due to potential mislabeling of crown sizes, which could lead to incorrect use in medical procedures.
“DIAMONDBACK 360 GEN2 Orbital Atherectomy System Recall: Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62182-diamondback-360-gen2-orbital-atherectomy-system-recall-mislabeling-risk. Based on FDA recall #Z-2385-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2385-2021%22&limit=1).
Cardiovascular Systems Inc voluntarily recalled one DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM on July 21, 2021, according to the FDA. The device may be mislabeled regarding OAD crown sizes.
How to tell if you have it
Brand: Cardiovascular Systems
Product: DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM
REF: DBP-150SOLID145
Lot: 340925
The hazard
The FDA stated there is a potential mislabeling of the OAD crown sizes, where 1.50mm Sold Crown OADs may be packaged as 1.25mm Micro Crown OADs and vice versa.
Context
GovInfoNow's records show Cardiovascular Systems Inc has three other recalls on record since September 14, 2017. Other recent recalls of similar products include the Micro Therapeutics Pipeline Flex Embolization Device Recall (June 25, 2026), the Olympus POWERSEAL 5mm 23cm Sealer Recall (August 18, 2026), and another Micro Therapeutics Pipeline Flex Embolization Device recall (June 8, 2026).
How to tell if you have this one
Check for the model name 'DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145' and lot number 340925.
Brand
Cardiovascular Systems
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Recall number
Product, codes & lots
Z-2385-2021
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145; Lot 340925
Z-2386-2021
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO; Lot 340931
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model name and lot number on the product packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, Florida, Iowa, Ohio, Pennsylvania, South Carolina, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2385-2021 (July 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2385-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.