Device recall
Z-2431-2025: WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2431-2025 |
|---|---|
| Recall event | 97363 |
| Product | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. |
| Product code | DQY |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K180864 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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