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Cardiovascular Systems Inc recalls Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patient
Recalled February 14, 2018 · FDA recall Z-0506-2018 · Cardiovascular Systems
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. · FDA Class II
Units
8
Sold at
FL, IL, MI, MN, MO, NY, SC, TX, and WI
Description
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.
Product
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.
Manufacturer(s)
Cardiovascular Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →