Cardiovascular Systems recalls Diamondback 1.50 Solid OAD due to potential labeling mix-up
Cardiovascular Systems recalls Diamondback 1.5:0 Solid OAD devices due to potential labeling mix-up in two production lots. Affected units may have incorrect labeling, but no safety hazard is reported.
Lower-risk 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.
Contact the company
What happened, in plain English
Cardiovascular Systems is recalling a specific type of medical device because two production lots had potentially switched labels. This could mean users have the wrong model, but the recall does not indicate any safety risk to patients. Read more at govinfonow.com/recall/73018-cardiovascular-systems-recalls-diamondback-1-50-solid-oad-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/73018-cardiovascular-systems-recalls-diamondback-1-50-solid-oad-due-to · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0506-2018
Cite this page
“Cardiovascular Systems recalls Diamondback 1.50 Solid OAD due to potential labeling mix-up.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73018-cardiovascular-systems-recalls-diamondback-1-50-solid-oad-due-to. Based on FDA recall #Z-0506-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0506-2018%22&limit=1).
Why it’s dangerous
The recall states that labeling for two production lots was potentially switched during manufacturing. This means some users might have the incorrect model number, but the device itself is not unsafe for use in patients.
Who’s affected
Medical professionals who use the Diamondback 1.50 Solid OAD device may have the wrong model due to labeling mix-up. Patients using the device are not at risk as the recall does not indicate a safety hazard.
How to tell if you have this one
Check for lot numbers 190217 and part number 7-10011 on the device. The model number DBP-150SOLID145 is also associated with the affected units.
- Brand
Cardiovascular Systems- Category
Medical device
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
FL, IL, MI, MN, MO, NY, SC, TX, and WI
| Recall number | Product, codes & lots |
|---|---|
| Z-0505-2018 | 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.; Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145 |
| Z-0506-2018 | Peripheral Diamondback 1.50 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.; Lot # 190217 Part #: 7-10011 Model # DBP-150SOLID145 |
What to do — step by step
Check Device Labeling
Verify the lot number, part number, and model number on the device to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 9 states.
FDA distribution: “FL, IL, MI, MN, MO, NY, SC, TX, and WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Michigan, Minnesota, Missouri, New York, South Carolina, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0506-2018 (September 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0506-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.