Device recall
Z-0580-2015: IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0…
FDA device recall · Class II · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-0580-2015 |
|---|---|
| Recall event | 69818 |
| Product | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. |
| Product code | DRF |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2016 |
| 510(k) numbers | K122461 |
| FEI number | 3001236349 |
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