FDA Recall Terminated

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.

Recall: Z-1375-2016 · Initiated March 15, 2016

Recall

Recall Number: Z-1375-2016
Event Number: 73630
Firm: Merit Medical Systems, Inc.
FEI Number: 1721504
Product Code: DRC
Status: Terminated
Root Cause: Software design
Initiated: March 15, 2016
Terminated: August 22, 2016
Address: 1600 West Merit Parkway, South Jordan, UT, 84095

Description

Reason

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

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.

Distribution

Distributed to one customer in the US.

Quantity