Recall Z-1375-2016 ยท DRC Trocar
Merit Medical Systems, Inc.
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.
| Date | Mar 15, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | The consignee was provided verbal and written notification of the field action on March 15, 2016. There was a total of one (1) consignee, an OEM customer in the USA, who received 25 units. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue distribution, and instructions to initiate a product recall in accordance with their company's established policies for customers to whom they shipped the affected Merit product. An email notification was sent to the Merit sales representative of the affected account. The sales |
| Quantity | 25 |
| Distribution | Distributed to one customer in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011727 | TRANSSEPTAL NEEDLE/TROCAR Thomas Medical Products, Inc., May 2, 2002 |