Device recall
Z-2459-2012: Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only…
FDA device recall · Class II · Greatbatch Medical
Key facts
| Recall number (Z-number) | Z-2459-2012 |
|---|---|
| Recall event | 63141 |
| Product | Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of… |
| Product code | DRA |
| Recalling firm | Greatbatch Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2015 |
| 510(k) numbers | K112541 |
| FEI number | 2183787 |
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