FDAMarch 15, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

merit medical systemsmeritmerit medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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