FDA-Device2018-02-14Class II
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.
Cardiovascular Systems Inc
Hazard
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.
Sold states
FL, IL, MI, MN, MO, NY, SC, TX, and WI
Affected count
8
Manufactured in
1225 Old Highway 8 NW, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0505-2018Don't want to check this manually?
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