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U.S. Department of Health and Human Services

Class 1 Device Recall Penumbra Neuron Delivery Catheter 070

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 Class 1 Recall
Penumbra Neuron Delivery Catheter 070
see related information
Date Posted October 05, 2009
Recall Status1 Terminated on November 24, 2010
Recall Number Z-0001-2010
Recall Event ID 53426
Premarket Notification
510(K) Number
K082290 
Product Classification Catheter, Percutaneous - 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.
Recalling Firm/
Manufacturer
Penumbra Inc.
1351 Harbor Bay Pkwy
Alameda, California 94502-6541
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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = PENUMBRA, INC.
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