Device recall
Z-1375-2016: Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1375-2016 |
|---|---|
| Recall event | 73630 |
| 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. |
| Product code | DRC |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2016 |
| 510(k) numbers | K011727 |
| FEI number | 1721504 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database