FDA Issues Recall of Penumbra, Inc.'s Stroke Catheter
12/10/2010 7:20:54 AM
MedPage Today -- The FDA announced a class I recall -- its most serious -- of a single lot of a catheter used in stroke patients, due to a joint failure that may prevent blood from flowing to the brain. Device maker Penumbra recalled lot F15020 of the Penumbra System Reperfusion Catheter 032 on Oct. 25 following a manufacturing error that can result in mid-shaft joint failures, which may cause serious injury or death in patients.
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