Penumbra Neuron 6F 070 Delivery Catheter - Class I Recall
MedSun: Newsletter #42, November 2009

FDA MedWatch Safety Alert

Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Facilities that have the recalled device should stop using and return it.

Additional Information:

FDA MedWatch Safety Alert. Penumbra Neuron 6F 070 Delivery Catheter. October 1, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm184742.htm


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