FDA-Device2016-04-20Class II
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.
Merit Medical Systems, Inc.
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
Sold states
Distributed to one customer in the US.
Affected count
25
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2016Don't want to check this manually?
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