Class 1 Device Recall Penumbra Neuron Delivery Catheter 070

• Date Initiated by Firm: September 22, 2009
• Date Posted: October 05, 2009
• Recall Status: Terminated on November 24, 2010
• Recall Number: Z-0001-2010
• Recall Event ID: 53426
• 510(K)Number: K082290
• Product Classification: Percutaneous Catheter - Product Code DQY
• Product: Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
• Code Information: Lot numbers F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560, and F14629.
• FEI Number: 3005168196
• Recalling Firm/ Manufacturer: Penumbra Inc.; 1351 Harbor Bay Pkwy; Alameda CA 94502-6541
• For Additional Information Contact: 510-748-3200
• Manufacturer Reason for Recall: Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.
• FDA Determined Cause: Device Design
• Action: The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penumbra Inc.; and complete and return the attached product identification / return form.
• Quantity in Commerce: 2246 units
• Distribution: Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.
• 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