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U.S. Department of Health and Human Services

Class 1 Device Recall Penumbra Neuron Select Catheter

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 Class 1 Recall
Penumbra Neuron Select Catheter
see related information
Date Posted September 08, 2009
Recall Status1 Open
Recall Number Z-2049-2009
Recall Event ID 52963
Premarket Notification
510(K) Number
K083125 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
Code Information Catalog Number: PNS5f130H1; Lot Number: F15174.
Recalling Firm/
Manufacturer
Penumbra Inc.
1351 Harbor Bay Pkwy
Alameda, California 94502-6541
Manufacturer Reason
for Recall
Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra. For further information, contact Penumbra, Inc. at 1-510-748-3223.
Quantity in Commerce 9 units
Distribution Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
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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