Recall Z-1808-2013— Stryker Neurovascular

Class II FDA medical device recall by Stryker Neurovascular, initiated 2013-06-24, terminated 2013-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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)..

Recalling firm

Stryker Neurovascular

Classification

Class II

Status

Terminated

Initiated

2013-06-24

Terminated

2013-09-30

Firm location

Fremont, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.