Class 2 Device Recall Penumbra Neuron Delivery Catheter 053

• Date Initiated by Firm: July 01, 2009
• Date Posted: September 24, 2009
• Recall Status: Terminated on November 30, 2010
• Recall Number: Z-2313-2009
• Recall Event ID: 52989
• 510(K)Number: K070970
• Product Classification: Percutaneous catheter - Product Code DQY
• Product: Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
• Code Information: Catalog number PND6F11512M, lot number F14751
• Recalling Firm/ Manufacturer: Penumbra Inc.; 1351 Harbor Bay Pkwy; Alameda CA 94502-6541
• For Additional Information Contact: 510-618-3223
• Manufacturer Reason for Recall: Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
• FDA Determined Cause: Mixed-up of materials/components
• Action: Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.
• Quantity in Commerce: 37 units
• Distribution: CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY