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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 Device Recall Penumbra Neuron Select Catheter see related information
Date Initiated by Firm July 02, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-2049-2009
Recall Event ID 52963
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 CA 94502-6541
For Additional Information Contact
510-618-3223
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		 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 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 and Original Applicant = PENUMBRA, INC.
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