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Class I Recall On Penumbra Revascularization Device

 
• By Elizabeth Orr

A delivery wire in the stroke treatment device can break or separate during use, putting patients at risk of worsened stroke, death and other adverse events.

Wire in Penumbra Inc.’s 3D Revascularization Device can endanger patients by breaking or separating during use, US FDA said in announcing a voluntary class I recall of the device.

Class I recalls are reserved for issues that could lead to serious injuries or death. In this case, the recall follows reports of a delivery wire within the revascularization device...

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