Class 2 Device Recall Boston Scientific TSX Transseptal Needle

• Date Initiated by Firm: March 15, 2016
• Create Date: April 12, 2016
• Recall Status: Terminated on August 22, 2016
• Recall Number: Z-1375-2016
• Recall Event ID: 73630
• 510(K)Number: K011727
• Product Classification: Trocar - Product Code DRC
• Product: Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
• Code Information: Lot Q823423, Exp 7/31/2018
• FEI Number: 1721504
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 West Merit Parkway; South Jordan UT 84095
• For Additional Information Contact: 801-253-1600 Ext. 349
• Manufacturer Reason for Recall: Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50 curve, rather than the correct 86 curve
• FDA Determined Cause: Software design
• Action: The consignee was provided verbal and written notification of the field action on March 15, 2016. There was a total of one (1) consignee, an OEM customer in the USA, who received 25 units. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue distribution, and instructions to initiate a product recall in accordance with their company's established policies for customers to whom they shipped the affected Merit product. An email notification was sent to the Merit sales representative of the affected account. The sales representative was provided a Customer Response Form applicable to their account. The sales representative was instructed to assist the account with the completion of the Customer Response Form and the return of the affected units back to the Merit Field Assurance Department.
• Quantity in Commerce: 25
• Distribution: Distributed to one customer in the US.
• 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 = DRC