Device recall
Z-0854-2011: Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization…
FDA device recall · Class II · Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
Key facts
| Recall number (Z-number) | Z-0854-2011 |
|---|---|
| Recall event | 57179 |
| Product | Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. |
| Product code | HGC |
| Recalling firm | Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2012 |
| 510(k) numbers | K012985, K031168 |
| FEI number | 2939204 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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