Penumbra Recalls the Original Version of 6F Neuron 070 Delivery Catheter

Full Story at usrecallnews.com

Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death.

Consumers who have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device. If your facility is in possession of units with Lot numbers F14630 or higher, you may continue to use these units. Units with Lot numbers F14630 or higher are not affected by this Field Removal Action.

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