Device recall
Z-2013-2009: Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2013-2009 |
|---|---|
| Recall event | 52826 |
| Product | Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX. Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They… |
| Product code | DQO |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2012 |
| 510(k) numbers | K970823, K974684, K981788 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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