Penumbra System RED 68 Reperfusion Catheter

Product Penumbra System RED 68 Reperfusion Catheter Issue Medical devices - Performance What to do Notification of customers. Return affected devices. Audience Healthcare

Penumbra has identified an issue in the lots of RED 68 specified in this notification which may result in potential fracture of the device. Penumbra has not received reports of any events involving patient injury related to these fractures; however, fracture of the catheter may result in patient injury or death.

RA-82240