Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Peripheral Diamondback 1.50 Solid OAD Recalled by Cardiovascular Systems Inc Due to Cardiovascular Systems, Inc. (CSI) is removing the products...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiovascular Systems Inc directly.
Affected Products
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.
Quantity: 8
Why Was This 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.
Where Was This Sold?
This product was distributed to 9 states: FL, IL, MI, MN, MO, NY, SC, TX, WI
About Cardiovascular Systems Inc
Cardiovascular Systems Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report