Merit Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1375-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 15, 2016

Date Posted: April 20, 2016

Recall Number: Z-1375-2016

Event ID: 73630

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

Status: Terminated

Product Quantity: 25

Code Information:

Lot Q823423, Exp 7/31/2018

Distribution Pattern:

Distributed to one customer in the US.

Voluntary or Mandated:

Voluntary: Firm initiated