Class I Recall of Stroke Catheter (Penumbra System Reperfusion Catheter 032)
Abstract:The Penumbra System Reperfusion Catheter 032 was marketed as a device used to re-establish blood supply to the brain, in patients experiencing stroke. However, the device maker Penumbra, after consultation with the FDA, issued a class I recall on their Reperfusion Catheters 032, belonging to lot F15020.
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