Cardiovascular Systems Inc recalls Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patien…

Recall date

September 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0505-2018

FDA classification

Class II

Brand / firm

Cardiovascular Systems Inc

Sold / distributed

FL, IL, MI, MN, MO, NY, SC, TX, and WI

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.