Device recall
Z-1342-2016: Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1342-2016 |
|---|---|
| Recall event | 73633 |
| Product | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature. |
| Product code | DXE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 11, 2017 |
| 510(k) numbers | K101354 |
| FEI number | 3002095335 |
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