Penumbra Inc.: 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.

Recall number

Z-1906-2011

Recalling firm

Penumbra Inc.

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.

Status

Terminated

Initiated

2011-03-04

Posted

2011-04-12

Terminated

2011-06-06

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

["K103305"]

PMA numbers

not on file

Product code

HCG

Firm FEI

3005168196

Firm city

Alameda

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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