—#144636

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.

FDA product code: DRC — Trocar
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011727
Affected lot / code info: Lot Q823423, Exp 7/31/2018

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern: Distributed to one customer in the US.

Timeline

Recall initiated: 2016-03-15
Terminated: 2016-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144636. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.