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
- Recall Number
- Z-1906-2011
- Event Number
- 58175
- Firm
- Penumbra Inc.
- FEI Number
- 3005168196
- Product Code
- HCG
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- March 4, 2011
- Posted
- April 12, 2011
- Terminated
- June 6, 2011
- Address
- 1351 Harbor Bay Pkwy, Alameda, CA, 94502-6541
Description
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.
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.
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 [email protected].
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.
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