Cardiovascular Systems controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
Cardiovascular Systems recalls Wirion device
Recall announced
Cardiovascular Systems Inc. initiated a U.S. recall of its Wirion atherectomy embolic protection device after reports of filter breakage during retrieval; the FDA identified it as a Class I recall.
Source excerpt
The company initiated the recall Nov. 22, 2021, when CSI sent an urgent notification recall letter to customers instructing them remove the device from distribution and return the device to Cardiovascular Systems Inc.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.