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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
Recall Number Z-1808-2013
Classification Class II
Code Info Code: M003450200, Lot 15391019, Expiration Date: 2015-07
Product Distributed Qty 23 units
Reason For Recall The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).

Event Detail

Event Id 65654
Product Type Devices
Status Ongoing
Recalling Firm Stryker Neurovascular
City Fremont
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern International Distribution including Austria, China, and Germany.