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U.S. Department of Health and Human Services

Class 1 Device Recall Penumbra brand Penumbra Coil System, Penumbra Coil 400

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  Class 1 Device Recall Penumbra brand Penumbra Coil System, Penumbra Coil 400 see related information
Date Initiated by Firm March 04, 2011
Date Posted April 12, 2011
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-1906-2011
Recall Event ID 58175
510(K)Number K103305  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA
The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Microcatheter.
Code Information F17211, F17212, F17213, F17214, F17215, F17216, F17256, F17257, F17258, F17259, F17260, F17310, F17311, F17333, F17334, F17335, F17336, F17337, F17338, F17339, F17340, F17374, F17375, F17376, F17395, F17396, F17397, F17398, F17399, F17400, F17401, F17402, F17403, F17404, F17405, F17440, F17441, F17442, F17443, F17444, F17445, F17446, F17447, F17448, F17485, F17486, F17487, F17489, F17507, F17511, F17512, F17513, F17514, F17515, F17516, F17517, F17564, F17565, F17566, F17567, F17568, F17569, F17668, F17669, F17670, F17672, F17673, F17675, F17676, F17705, F17706, F17707, F17708, F17710, F17735, F17736, F17737, F17738, F17739, F17740, F17741, F17742, F17743, F17744, F17745, F17780, F17781, F17782, F17783, F17790, F17791, F17792, F17793, F17794, F17833, F17834, F17835, F17836, F17837, F17838, F17839, F17840, F17841, F17842, F17843, F17844, F17900, F17901, F17902, F17903, F17904, F17905, F17906, F17907, F17908, F17924, F17925, F17926, F17927, F17928 , F17929, F17930, F17931, F17932, F17933, F17934, F17935, F17936, F17966, F17967, F17968, F17969, F17970, F17971, F17972, F17973, F17974, F17975, F17976, F17977, F17999, F18000, F18001, F18002, F18021, F18022, F18023, F18024, F18041, F18042, F18043, F18044, F18045, F18046, F18047, F18066, F18068, F18073, F18074, F18075, F18076, F18090, F18091, F18092, F18093, F18094, F18121, F18122, F18123, F18124, F18125, F18126, F18127, F18128, F18129, F18146, F18147, F18148, F18149, F18150, F18151, F18152, F18153, F18179, F18180, F18181, F18182, F18183, F18184, F18185, F18186, F18194, F18195, F18196, F18197, F18231, F18232, F18233, F18234, F18235, F18236, F18239, F18240, F18241, F18242, F18243, F18244, F18245, F18246, F18247, F18248, F18249, F18291, F18292, F18293, F18294, F18295, F18307, F18308, F18309, F18336, F18337, F18338, F18373, F18374, F18375, F18387, F18388, F18389, F18400, F18401, F18415, F18416, F18417, F18449, F18450, F18451, F18457, F18458, F18459, F18460, F18461, F18479, F18480, F18481, F18482, F18483, F18484, F18485, F18486, F18487, F18488, F18513, F18514, F18515, F18516, F18517, F18518, F18519, F18520, F18521, F18550, F18551, F18552, F18553 
Recalling Firm/
Manufacturer		 Penumbra Inc.
1351 Harbor Bay Pkwy
Alameda CA 94502-6541
For Additional Information Contact Wendy Ruiz
510-748-3200
Manufacturer Reason
for Recall		 The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.
FDA Determined
Cause 2		 Process change control
Action Penumbra sent an Urgent Voluntary Field Removal Notice dated March 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately inspect all stock of Penumbra Coil 400 and identify product from the Lots. Remove product from these Lots from inventory and place it in quarantine for return to Penumbra Inc. (Do not use product from these Lots). Complete and return the attached product identification/ return form with in 5 business days via fax to +1 510-217-6414. Penumbra employees will contact customer directly to arrange return and replacement of product. For questions call Regulatory Affairs at 510-748-3224 or e-mail RAQA@prenumbrainc.com.
Quantity in Commerce 2082
Distribution Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom and Switzerland) and South Africa.
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 = HCG and Original Applicant = PENUMBRA, INC.
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