FDA Device recall Z-1375-2016
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o by Merit Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1375-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-15 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merit Medical Systems |
| Distribution | n/a |
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.
Reason
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
Identifiers
| code_info | Lot Q823423, Exp 7/31/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1375-2016%22
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