Class 2 Device Recall Maestro Microcatheter

• Date Initiated by Firm: December 06, 2013
• Date Posted: December 31, 2013
• Recall Status: Terminated on January 27, 2014
• Recall Number: Z-0614-2014
• Recall Event ID: 67128
• 510(K)Number: K082613
• Product Classification: Catheter, continuous flush - Product Code KRA
• Product: Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
• Code Information: Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 West Merit Parkway; South Jordan UT 84095
• For Additional Information Contact: Paul Kennedy; 801-253-1600 Ext. 349
• Manufacturer Reason for Recall: Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
• FDA Determined Cause: Packaging process control
• Action: Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, 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 discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.
• Quantity in Commerce: 59
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada.
• 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 = KRA