| Class 1 Device Recall Penumbra Neuron Select Catheter | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQY
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