Merit Medical Systems, Inc. recalls Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatri…

Recall date

March 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1375-2016

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

Distributed to one customer in the US.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.