A recall initiated by Penumbra involving 155 units of its Penumbra 3D Revascularization device, designed for acute ischemic stroke, has been classified by the FDA as Class I. The recall was issued because the device's delivery wire may separate or break during thrombus removal, posing risks of serious adverse events and death if fractured pieces of the wire are left inside the brain.
Recall of Penumbra's revascularization device labeled Class I by FDA
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