Important Safety Alerts

Medical device manufacturer, Penumbra Inc., has issued a medical device safety alert concerning Neuron MAX Catheters. The affected catalogue numbers are as follows:

• PNMD8F088804M - 8F 088 Neuron MAX 088 Delivery Catheter 80/4 MP
• PNMD8F088904M - 8F 088 Neuron MAX 088 Delivery Catheter 90/4 MP
• PNML6F088804M - 6F 088 Neuron MAX Long Sheath 80/4 MP
• PNML6F088904M - 6F 088 Neuron MAX Long Sheath 90/4 MP
• PNML6F0881004M - 6F 088 Neuron MAX Long Sheath 100/4 MP

The manufacturer has recently identified that, for some Neuron MAX Catheters, it is possible for the packaging mandrel to remain within the catheter during removal. When this occurs, the catheter tip can be damaged. This is due to reduced adherence of the mandrel to the packaging card.

The manufacturer advises affected users to take the following preventive actions:

• Follow the product Instructions For Use and remove the device carefully
• Inspect the device prior use to detect any damage has occurred to the product during the removal from the packaging.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 October 2013